SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
____________
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported) July 21, 1994
Biocraft Laboratories, Inc.
(Exact name of registrant as specified in charter)
Delaware 1-8867 22-1734359
(State or other jurisdiction (Commission (IRS employer
of incorporation) file number) identification no.)
18-01 River Road, Fair Lawn, New Jersey 07410
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (201) 703-0400
_________________________________________________________________
(Former name or former address, if changed since last report)
<PAGE>
Item 5. Other Events.
On July 21, 1994, the registrant issued a news release
announcing that it had reached agreement with the U.S. Food and
Drug Administration (the "FDA") setting forth steps to resolve
outstanding regulatory issues with respect to its dosage form
facilities. The terms of the agreement with the FDA are
contained in the consent decree included as an exhibit with this
report.
The foregoing summary is qualified in its entirety by
reference to the news release and consent decree included with
this report.
Item 7. Financial Statements, Pro Forma
Financial Information and Exhibits.
(c) Exhibits
99.1 News release issued July 21, 1994
99.2 Form of Consent Decree of Permanent
Injunction
SIGNATURES
Pursuant to the requirements of the Securities Exchange
Act of 1934, the registrant has duly caused this report to be
signed on its behalf by the undersigned hereunto duly authorized.
Biocraft Laboratories, Inc.
(Registrant)
Date July 25, 1994 By s/
Beryl L. Snyder,
Vice President and
General Counsel
<PAGE>
Exhibit Index
Exhibit Number Page
99.1 News Release issued July 21, 1994 4
99.2 Form of Consent Decree of Permanent 6
Injunction
Exhibit 99.2
FRANK W. HUNGER
Assistant Attorney General
Civil Division
FAITH S. HOCHBERG
United States Attorney
SUSAN C. CASSELL
Assistant United States Attorney
970 Broad Street, Room 502
Newark, New Jersey 07102
Tel: (201) 645-2844
JAY I. BRATT
Office of Consumer Litigation
U.S. Department of Justice
P.O. Box 386
Washington, D.C. 20044
Tel.: (202) 307-0414
Attorneys for Plaintiff
S.C. 8081
J.B. 2940
IN THE UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
UNITED STATES OF AMERICA, : Civil No.
Plaintiff, :
-vs- : CONSENT DECREE
OF PERMANENT
BIOCRAFT LABORATORIES, INC., : INJUNCTION
a corporation, and
HAROLD SNYDER, individually :
and as president and chief
executive officer of Biocraft :
Laboratories, Inc.,
:
Defendants.
The United States of America, Plaintiff herein, by Faith S.
Hochberg, United States Attorney for the District of New Jersey,
having filed a Complaint for injunction against Biocraft
Laboratories, Inc. ("Biocraft"), a corporation, and Harold
Snyder, an individual, and Defendants, without admitting any of
the allegations in the complaint and disclaiming any liability in
connection therewith, having appeared and having consented to
entry of this Decree without contest and before any testimony has
been taken, and the United States of America having consented to
the entry of this Decree and having moved this Court for this
Injunction:
IT IS HEREBY ORDERED, ADJUDGED, AND DECREED that:
1. This Court has jurisdiction over the subject matter
herein and has personal jurisdiction over all parties to this
action.
2. The complaint for injunction states a cause of action
against Defendants under the Federal Food, Drug, and Cosmetic
Act, 21 U.S.C. Secs. 301 et seq.
3. Defendants and each and all of their officers, agents,
directors, representatives, employees, attorneys, successors and
assigns, and any and all persons in active concert or
participation with any of them, are hereby permanently restrained
and enjoined from directly or indirectly doing or causing the
introduction or delivery for introduction into interstate
commerce, and the manufacturing, processing, packing, or labeling
(except for validation purposes), while held for sale after
shipment of one or more of its components in interstate commerce,
of certain articles of drug, as defined by 21 U.S.C. Sec. 321(g)
(hereinafter referred to as "drug"), including Amoxicillin for
Oral Suspension ("FOS") (Human and veterinary), Amiloride with
Hydrochlorothiazide ("HCTZ"), Nystatin Oral Suspension, and
Ampicillin FOS, and any other drug product not in compliance with
the requirements of paragraphs 4, 5, and 6 below, unless and
until:
a. The methods used in, and the facilities and
controls used for, the manufacturing, processing, packing,
labeling, or holding of these articles of drug are established,
administered, and operated in conformity with 21 U.S.C.
Sec. 351(a)(2)(B) and the current, good manufacturing practice
("CGMP") regulations as set forth at 21 C.F.R. Parts 210 and 211;
b. Defendants select an independent person or
persons who by reason of training and experience are qualified to
make inspections of drug manufacturing facilities and
laboratories (hereinafter referred to as "expert") to inspect
Defendants' manufacturing and laboratory facilities and certify
in writing, with supporting documentation, to the Food and Drug
Administration ("FDA") that:
(1) the manufacturing processes used for
Amoxicillin FOS (Human and Veterinary), Amiloride with HCTZ,
Nystatin Oral Suspension, and Ampicillin FOS are validated;
(2) the in-process, finished product, and
stability test methods are validated for Amoxicillin FOS (Human
and Veterinary), Amiloride with HCTZ, Nystatin oral suspension,
and Ampicillin FOS, and the number of tests is sufficient to
ensure that each drug product has the identity and strength, and
meets the quality and purity characteristics which it purports or
is represented to possess;
(3) a stability plan, including a stability
protocol, is in place for each drug product listed in
subparagraph (b)(1) above;
(4) a failure investigation procedure is
established and administered that requires Defendants to:
(a) identify and document the probable cause(s) of each failure
or take reasonable steps to identify the probable cause(s) of
each failure and reasonably conclude that the probable cause(s)
cannot be determined; (b) extend an investigation to other
batches of the same drug product, including previous batches with
the same or similar failures, and other drug products that may
have been associated with the failure; (c) document the
investigation fully in a report that is signed by the person who
conducted the investigation and that includes a description of
any corrective action taken; and (d) require review and approval
of the report by the quality unit director or a person of
equivalent or higher responsibility for the release of finished
product lots;
(5) Defendants, with the assistance of one
or more experts, have trained each analyst in the proper use of
all test methods and applicable laboratory equipment. The expert
shall certify to FDA in writing for each analyst: (a) the name
of the expert conducting, supervising, or reviewing the training,
(b) the test methods in which, and the equipment on which, an
analyst has been trained, and (d) the date(s) on which the
analyst received each type of training;
(6) the methods (excluding those for any
product not identified in subparagraph 3(b)(1) above),
facilities, and controls at each of Defendants' facilities where
each product listed in subparagraph 3(b)(1) is manufactured and
stored are established, administered, and operated in conformity
with 21 U.S.C. Sec. 351(a)(2)(B) and the CGMP regulations as set
forth at 21 C.P.R. Parts 210 and 211; and
(7) the methods (excluding those for any
product not identified in subparagraph 3(b)(1) above), equipment,
recordkeeping, and controls at each of Defendant's laboratories
are established, administered, and operated in conformity with 21
U.S.C. Sec. 351(a)(2)(B) and the CGMP regulations as set forth at
21 C.F.R. Parts 210 and 211.
c. Such certification is submitted to the
District Director of the Newark District office, United States
Food and Drug Administration, Department of Health and Human
Services, 61 Main Street, West Orange, New Jersey 07052
(hereinafter referred to as "the Newark District Office"), for
FDA's review and evaluation and FDA notifies Defendants in
writing that FDA accepts such certification;
d. Defendants report to FDA in writing the
actions they have taken to ensure that the methods, facilities,
and controls used in and for the laboratories and the
manufacturing, processing, packing, labeling, and holding of
these drugs have been established and will be administered and
operated continuously in conformity with 21 U.S.C.
Sec. 351(a)(2)(B) and the CGMP regulations as set forth at 21
C.F.R. Parts 210 and 211;
e. After FDA receives the submissions required
under subparagraphs 3(b) and 3(d) above, duly authorized FDA
representatives make one or more inspections, as described in
paragraph 12 herein. FDA shall exercise its best efforts to
begin such an inspection within ton (10) business days after
receiving the submissions pursuant to subparagraphs 3(b) and 3(d)
or notify Defendants in writing that no inspection will occur;
f. FDA notifies Defendants in writing that
Defendants' manufacturing (including testing methods),
processing, packing, labeling, and storage of such drugs appear
to be in conformity with the requirements set forth herein and
with 21 U.S.C. Sec. 351(a)(2)(B) and the CGMP regulations as set
forth at 21 C.F.R. Parts 210 and 211. FDA shall exercise its
best efforts to provide such notification within ten (10)
business days after completing each inspection for each product
conducted pursuant to subparagraph 3(e) above; and
g. After submission to FDA of the expert
certification for Amoxicillin FOS (Human and Veterinary) pursuant
to subparagraph 3(c) above, Defendants may resume manufacturing
of these drugs at their own risk provided that such drugs are
held in quarantine and are destroyed upon FDA's request if FDA
determines, pursuant to subparagraph 3(f) above, that Defendants
do not appear to be in conformity with the requirements set forth
herein and with 21 U.S.C. Sec. 351(a)(2)(B) and the CGMP
regulations as set forth at 21 C.P.R. Parts 210 and 211.
Defendants may release the drugs from quarantine if FDA
determines, pursuant to paragraph 3(f) above, that Defendants
appear to be in conformity with the requirements set forth herein
and with 21 U.S.C. Sec. 351(a)(2)(B) and the CGMP regulations as
set forth at 21 C.F.R. Parts 210 and 211.
4. Notwithstanding paragraph 3 above, no provision of this
Decree shall prohibit Defendants from continuing to manufacture
and distribute Clindamycin, Caphalexin FOS, Cephradine FOS and
capsules, and Amitriptyline so long as the following conditions
have been met:
a. Within fourteen (14) days after the entry of this
Decree, Defendants select an expert to inspect Defendants'
facilities, laboratories, and manner of operating to evaluate
whether the methods used in, and the facilities and controls used
for, the manufacturing, processing, packing, labeling, and
holding of clindamycin, Cephalexin FOS, Cephradine FOS and
capsules, and Amitriptyline are established, administered, and
operated by Defendants in conformity with 21 U.S.C.
Sec. 351(a)(2)(B) and the CCMP regulations as set forth at 21
C.F.R. Parts 210 and 211; and such expert submits to FDA, within
those <PAGE>
fourteen (14) days, written certification, with documentation,
for each of these drug products that:
(1) the manufacturing process used for Cephalexin
FOS is validated;
(2) the in-process, finished product, and
stability test methods for Clindamycin, cephalexin FOS,
Caphradine FOS and capsules, and Amitriptyline are validated and
the number of tests is sufficient to ensure that each drug
product has the identity and strength, and meets the quality and
purity characteristics which it purports or is represented to
possess;
(3) a stability plan, including a stability
protocol, is in place for each drug product listed in
subparagraph 4(a)(1) above. In addition, with respect to
Cephradine FOS and capsules, an expert shall certify and provide
documentation that there are sufficient stability data to support
a reduced eighteen (18) month expiration date; and
(4) a failure investigation procedure is
established and administered that requires Defendants to:
(a) identify and document the probable cause(s) of each failure
or take reasonable steps to identify the probable cause(s) of
each failure and reasonably conclude that the probable cause(s)
cannot be determined; (b) extend an investigation to other
batches of the same drug product, including previous batches with
the same or similar failures, and other drug products that may
have been associated with the failure; (c) document the
investigation fully in a report that is signed by the person who
conducted the investigation and that includes a description of
any corrective action taken; and (d) require review and approval
of the report by the quality unit director or a person of
equivalent or higher responsibility for the release of finished
product lots;
b. The expert certifies to FDA in writing, within
thirty (30) days after the certification required under
subparagraph 4(a) above, the following:
(1) the methods (excluding those for any product
not identified in subparagraph 4(a) above), facilities, and
controls at each of Defendants' facilities where each product
listed in subparagraph 4(a) is manufactured and stored are
established, administered, and operated in conformity with 21
U.S.C. Sec. 351(a)(2)(B) and the CGMP regulations as set forth at
21 C.F.R. Parts 210 and 211; and
(2) the methods (excluding those for any product
not identified in subparagraph 4(a) above), equipment,
recordkeeping, and controls at each of Defendants' laboratories
are established, administered, and operated in conformity with 21
U.S.C. Sec. 351(a)(2)(B) and the CGMP regulations as set forth at
21 C.F.R. Parts 210 and 211.
c. FDA notifies Defendants in writing that FDA
accepts such certification.
d. In the event that FDA does not accept the expert's
certification for any drug identified in subparagraph 4(a),
Defendants shall cease manufacturing and distributing the drug
within forty-eight (48) hours after receiving notice of FDA's
decision.
5. Notwithstanding paragraph 3 above, no provision of this
Decree shall prohibit Defendants from continuing to manufacture
and distribute Albuterol Sulfate tablets, Metoclopramide tablets,
Disopyramide capsules, Sulfamethoxazole with Trimethoprim
("SMZ/TMP") tablets and Oral Solution, and Amoxicillin Chewable
Tablets so long as the following conditions have been met:
a. Within one hundred and twenty (120) days after the
entry of this Decree, Defendants select an expert to inspect
Defendants' facilities, laboratories, and manner of operating to
evaluate whether the methods used in, and the facilities and
controls used for, the manufacturing, processing, packing,
labeling, and holding of Albuterol Sulfate tablets,
Metoclopramide tablets, Disopyramide capsules, SMZ/TMP tablets
and Oral Solution, and Amoxicillin Chewable Tablets are
established, administered, and operated by Defendants in
conformity with 21 U.S.C. Sec. 351(a)(2)(B) and the CGMP
regulations as set forth at 21 C.F.R. Parts 210 and 211; and such
expert submits to FDA, within those one hundred and twenty (120)
days, written certification, with documentation, for each of
these drug products that:
(1) the manufacturing process used for each of
these drug products has been validated according to a validation
protocol that includes the following:
(i) an evaluation of the prior history of
the product for the past two years;
(ii) validation of three consecutive lots has
been performed, with any failures at the blend or finished
product stage addressed in terms of the continued validity of the
manufacturing process;
(iii) bland testing of in-process dry material
must be conducted on samples taken from both the blender as well
as from the downloaded drums, must include at least 10 locations
from the most likely areas of non-uniformity in the blender as
well as two samples from the top, middle, and bottom of all
downloaded drums, and must use sample sizes that do not exceed
three (3) times the weight of the run weight of the dosage form;
and
(iv) finished product testing must include at
least sixty (60) finished dosage form units divided into two (2)
groups of thirty (30) being tested for content uniformity, and
all products must meet the USP content uniformity specifications;
(2) a failure investigation procedure is
established and administered that requires Defendants to:
(a) identify and document the probable cause(s) of each failure
or take reasonable steps to identify the probable cause(s) of
each failure and reasonably conclude that the probable cause(s)
cannot be determined; (b) extend an investigation to other
batches of the same drug product, including previous batches with
the same or similar failures, and other drug products that may
have been associated with the failure; (c) document the
investigation fully in a report that is signed by the person who
conducted the investigation and that includes a description of
any corrective action taken; and (d) require review and approval
of the report by the quality unit director or a person of
equivalent or higher responsibility for the release of finished
product lots;
(3) Defendants, with the assistance of one or
more experts, have trained each analyst in the proper use of all
test methods and applicable laboratory equipment. The expert
shall certify to FDA in writing for each analyst: (a) the name
of the expert conducting, supervising, or reviewing the training,
(b) the test methods in which, and the equipment on which, an
analyst has been trained, and, (d) the date(s) on which the
analyst received each type of training;
(4) the in-process, finished product, and
stability test methods are validated and the number of tests is
sufficient to ensure that each of these drug products has the
identity and strength, and meets the quality and purity
characteristics which it purports or is represented to possess;
(5) the methods (excluding those for any product
not identified in subparagraph 5(a) above), facilities, and
controls at each of Defendants' facilities where these drug
products are manufactured and stored are established,
administered, and operated in conformity with 21 U.S.C.
Sec. 351(a)(2)(B) and the CGMP regulations as set forth at 21
C.F.R. Parts 210 and 211; and
b. With respect to SMZ/TMP tablets and oral Solution,
Defendants reinstitute blend testing of in-process dry material
for 20 consecutive lots following revalidation; and
c. FDA notifies Defendants in writing that FDA
accepts such certification.
d. In the event that FDA does not accept the expert's
certification for any drug identified in subparagraph (a),
Defendants shall cease manufacturing and distributing the drug
within forty-eight (48) hours after receiving notice of FDA's
decision.
6. Notwithstanding paragraph 3 above, no provision of this
Decree shall prohibit Defendants from continuing to manufacture
and distribute any drug not identified in paragraphs 3-5 so long
as the following conditions have been met:
a. Defendants select an expert to inspect Defendants'
facilities, laboratories, and manner of operating to evaluate
whether the methods used in, and the facilities and controls used
for, the manufacturing, processing, packing, labeling, and
holding of any drug are established, administered, and operated
by Defendants in conformity with 21 U.S.C. Sec. 351(a)(2)(B) and
the CGMP regulations as set forth at 21 C.F.R. Parts 210 and 211.
Within eighteen (18) months after entry of this Decree, and
subject to a schedule submitted to FDA within fourteen (14) days
after entry of this Decree and approved by FDA, such expert
submits to FDA written certification, with documentation, for
each drug product (including clindamycin, Amitriptyline, and
Cephradine POS and capsules) that:
(1) the manufacturing process used for each drug
product is validated, including in such certification a list of
out-of-specification results for all lots produced within the
past two years or the last 20 lots, whichever is greater;
(2) a failure investigation procedure is
established and administered that requires Defendants to:
(a) identify and document the probable cause(s) of each failure
or take reasonable steps to identify the probable cause(s) of
each failure and reasonably conclude that the probable cause(s)
cannot be determined; (b) extend an investigation to other
batches of the same drug product, including previous batches with
the same or similar failures, and other drug products that may
have been associated with the failure; (c) document the
investigation fully in a report that is signed by the person who
conducted the investigation and that includes a description of
any corrective action taken; and (d) require review and approval
of the report by the quality unit director or a person of
equivalent or higher responsibility for the release of finished
product lots;
(3) Defendants, with the assistance of one or
more experts, have trained each analyst in the proper use of all
test methods and applicable laboratory equipment. The expert
shall certify to FDA in writing for each analyst: (a) the name
of the expert conducting, supervising, or reviewing the training,
(b) the test methods in which, and the equipment on which, an
analyst has been trained, and (d) the date(s) on which the
analyst received each type of training.
(4) the in-process, finished product, and
stability test methods are validated and the number of tests is
sufficient to ensure that each drug product has the identity and
strength, and meets the quality and purity characteristics which
it purports or is represented to possess; and
(5) the methods, facilities, and controls at each
of Defendants' facilities where the product is manufactured and
stored are established, administered, and operated in conformity
with 21 U.S.C. Sec. 351(a)(2)(B) and the CGMP regulations as set
forth at 21 C.P.R. Parts 210 and 211; and
b. FDA notifies Defendants in writing that FDA
accepts such certification.
c. In the event that FDA does not accept the expert's
certification for any drug subject to this paragraph, Defendants
shall cease manufacturing and distributing the drug within forty-
eight (48) hours after receiving notice of FDA's decision.
RECALLS
7. With respect to Amoxicillin FOS Human and veterinary,
Amiloride with HCTZ, Disopyramide capsules, Cephalexin FOS,
Nystatin oral Suspension, Ampicillin FOS, Amoxicillin Chewable
Tablets, and SMZ/TMP tablets, Defendants shall institute recalls
of those lots identified in Exhibit A to this Decree within
forty-eight (48) hours after entry of this Decree.
8. Defendants shall, within forty-eight (48) hours,
institute recalls of all other in-date drug product lots released
before November 1993, release of which were based upon High
Performance Liquid Chromatography ("HPLC") testing using computer
programmed correction factors, unless within sixty (60) days
after entry of this Decree:
a. Retention samples of ten (10) percent of such
finished drug product lots are retested and ninety-five (95)
percent of the lots tested are within all required specifications
that could have been affected by the use of computer programmed
correction factors; and
b. Such retesting is conducted by an independent
laboratory, which FDA has, in writing, approved for this purpose.
Alternatively, such retesting may be conducted at Defendants'
laboratories if Defendants' expert certifies in writing, and such
certification is accepted by FDA, that the laboratory methods are
revalidated using data that are not based upon the HPLC computer
programmed correction factors, that the methods are stability-
indicating, and that the analytical chemist performing such
retesting is certified by the expert to be adequately trained.
9. Defendants shall institute recalls of any and all other
lots of drug products that FDA deems necessary or appropriate.
Such recalls (including those conducted pursuant to paragraphs 7
and 8) shall be conducted in cooperation with FDA and in
accordance with the provisions of 21 C.P.R. Part 7. All costs of
the recalls, including the costs of FDA's involvement in the
recalls, shall be borne by Defendants.
GENERAL PROVISIONS
10. After Defendants have achieved compliance with the
terms of paragraphs 3 through 6 of this Decree, the Defendants
and each and all of their officers, directors, agents,
representatives, employees, attorneys, successors and assigns,
and any and all persons in active concert or participation with
them, are permanently restrained and enjoined from directly or
indirectly doing or causing to be done any of the following acts:
a. Violating 21 U.S.C. Sec. 331(a) by introducing or
delivering for introduction into interstate commerce any drug
that is adulterated within the meaning of 21 U.S.C.
Sec. 351(a)(2)(B), in that the methods used in, or the facilities
or controls used for, its manufacture, processing, packing, or
holding do not conform to, or are not operated or administered in
conformity with CGMP, as set forth in 21 C.F.R. Parts 210 and
211; and
b. Violating 21 U.S.C. Sec. 331(k) by manufacturing,
processing, packing, labeling, holding, or doing any other act
with respect to a drug while such drug is held for sale after its
shipment or shipment of one or more of its components in
interstate commerce, which act results in the drug being
adulterated within the meaning of 21 U.S.C. Sec. 351(a)(2)(B) and
21 C.F.R. Part 210 or 211.
11. Within thirty (30) days after receiving written
notification pursuant to paragraph 3(f) above, Defendants shall
retain an expert to conduct audit inspections, no less than twice
a year for a period of four (4) years, and to certify in writing
whether the facility remains in compliance with all requirements
set forth in 21 C.F.R. Parts 210 and 211. Such person or persons
shall prepare a written report on each facility and its operation
at the conclusion of each audit inspection. Certifications and
the full report of such inspections shall be available, upon
request, to an FDA representative during the course of any FDA
inspection conducted under the terms of this Decree or pursuant
to 21 U.S.C. Sec. 374.
12. FDA investigators are authorized to make inspections of
Defendants' facilities, as FDA deems necessary, including all
buildings, equipment, finished and unfinished materials,
containers, labeling and all other promotional materials; to take
photographs; and to examine and copy all records relating to the
receipt, manufacturing, processing, packing, labeling, holding,
and distribution of any of Defendants' drug products to ensure
continuing compliance with the terms of this Decree. Such
inspection shall be authorized upon presenting a copy of this
Decree and FDA credentials. The inspection authority pursuant to
this Decree is apart from and in addition to the authority to
make inspections pursuant to 21 U.S.C. Sec. 374.
13. At any time after Defendants have resumed operations,
pursuant to FDA notification under paragraph 3 (f) above, or have
received notification of FDA's acceptance of the certifications
pursuant to paragraphs 4(c), 5(c), and 6(b) above, Defendants
shall immediately cease and discontinue manufacturing, packing,
labeling, and distributing any drug if, after inspection,
investigation, laboratory analysis of samples, or other
information, FDA notifies Defendants in writing that Defendants
are not in compliance with this Decree or with 21 U.S.C.
Sec. 351(a)(2)(B) and the CGMP regulations as set forth at 21
C.F.R. Parts 210 and 211, with respect to that drug. This notice
of non-compliance may, as FDA deems appropriate, require the
Defendants to institute recalls; to issue safety alerts; to
revise labeling; and to take any other action provided by the Act
or implementing regulations.
14. Any cessation of operation as described in paragraph 13
above or pursuant to paragraphs 4(d), 5(d), and 6(c) above shall
continue until Defendants receive from FDA written notification
that Defendants appear to be in compliance with this Decree and
with 21 U.S.C. Sec. 351(a)(2)(B) and the CGMP regulations as set
forth at 21 C.F.R. Parts 210 and 211. Upon Defendants' written
request, FDA shall endeavor to determine whether Defendants
appear to be in compliance and, if so, issue to them written
notification permitting resumption of operation.
15. Defendants shall reimburse FDA for the costs of all FDA
inspections, examinations, and analyses that FDA deems necessary
to evaluate compliance efforts under this Decree, and the costs
of FDA's involvement in all recalls, at the following rates:
$49.00 per hour and any fraction thereof per representative for
inspectional work; $59.00 per hour and any fraction thereof per
representative for laboratory and analytical work; $0.25 per mile
for travel expenses; and $121.00 per day for subsistence
expenses, where reasonably necessary.
16. All FDA decisions rendered pursuant to this Decree
shall be vested in the discretion of FDA, and shall be delivered
in writing to the Defendants with an explanation for the
decision. Defendants shall abide by the decision of FDA, which
decision shall be final as provided in this Decree, or unless and
until overturned, modified, or stayed by the Court after review
as provided in this paragraph. Any FDA decision under this
Decree shall be reviewable by this court based solely upon the
written record before FDA when the decision is made. At
Defendants' request, the Plaintiff shall not oppose expedited
judicial review of any decision by FDA under this Decree. The
record shall be limited to any material before FDA when its
decision is made, including FDA's initial decision, Defendants'
response thereto, if any, and FDA's written reply to Defendants'
response, and any other material submitted to FDA by Defendants.
17. Defendants shall provide a copy of this Decree, by
personal service or registered mail, within ten (10) calendar
days of its entry, to each of their officers, agents,
representatives, employees, successors, assigns, attorneys, and
any and all persons in active concert or participation with any
or all of them, and shall provide the Director of the Newark
District office with an affidavit within thirty (30) calendar
days after the date of the entry of this Decree stating the fact
and manner of compliance with this paragraph and identifying the
name and title or position of each person so notified and the
manner of notification.
18. Defendants shall notify the Director of the Newark
District Office at least fifteen (15) calendar days before any
change in ownership or character of Defendants' business,
including, but not limited to: dissolution, assignment, or sale,
which change results in the emergence of a successor corporation,
creation or dissolution of subsidiaries, or any other change in
the corporate structure of Biocraft Laboratories, Inc., or the
sale or assignment of any business asset, such as buildings,
equipment, or inventory that may effect a change in ownership in
Defendants' business. Defendants shall provide a copy of this
Decree to any successor or assign at least thirty (30) calendar
days prior to any sale or assignment.
066 If Defendants violate this Decree and are found in
civil or criminal contempt thereof, Defendants shall, in addition
to other remedies, reimburse Plaintiff for attorney fees,
investigational and analytical expenses, administrative and court
costs, and any other costs or fees related to such enforcement
proceedings.
20. This Court retains jurisdiction of this action for the
purpose of modifying this Decree and for granting such additional
relief as may be necessary or appropriate.
21. This Decree's provisions shall not apply to Defendants'
bulk pharmaceutical manufacturing operations.
22. Defendants shall bear their own costs, including
attorney fees, for compliance with this Decree in addition to any
costs expressly provided herein.
We hereby consent to entry of the foregoing Decree.
___________________________ FRANK W. HUNGER
Biocraft Laboratories, Inc. Assistant Attorney General
by Harold Synder, President Civil Division
U.S. Department of Justice
________________________ FAITH S. HOCHBERG
Harold Snyder, United States Attorney
individually District of New Jersey
________________________
Roger C. Thies
Hyman, Phelps & By: _________________________
McNamara, P.C. Susan C. Cassell
Attorneys for Defendants Assistant United States
Attorney
970 Broad Street, Room 502
Newark, New Jersey 07102
Jay I. Bratt
Attorney
U.S. Department of Justice
P.O. Box 386
Washington, D.C. 20044
(202) 307-0414
Of Counsel:
Margaret Jane Porter
Chief Counsel
Areta L. Kupchyk
Assistant Chief Counsel for
Enforcement
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
SO ORDERED:
Dated this ________ day of July, 1994.
_________________________
United States District
Judge
EXHIBIT A
Product Lot(s)
Amiloride HCTZ All in-date lots
Amoxicillin FOS (Human) 29000
31212
31337
31340
31364
31954
33343
33351
33674
Amoxicillin FOS (Veterinary) All in-date lots
Amoxicillin Chewable Tablets 33269
Ampicillin FOS All in-date lots
Cephalexin FOS 52918
52923
52964
53047
Disopyramide capsules 20533
Nystatin Oral Suspension 20834
SMZ/TMP tablets 18030
18104
Exhibit 99.1
NEWS RELEASE
FOR IMMEDIATE RELEASE Contact: Harold Snyder
(201) 703-0400
Biocraft Reaches Agreement with FDA
Resolving Regulatory Issues
Fair Lawn, New Jersey, July 21, 1994 Biocraft
Laboratories, Inc. (NYSE:BCL) today announced that it has reached
agreement with the Food and Drug Administration setting forth
steps to resolve outstanding regulatory issues with respect to
its dosage form facilities.
Based on the agreement, the Company will suspend shipments
of Nystatin Oral Suspension and the Powder for Oral Suspension of
Amoxicillin (human and veterinary use) until independent expert
certifications are submitted to and approved by the FDA. The
Company expects that shipments should resume in a short period of
time. Previously, on its own initiative, the Company had delayed
shipments of the Oral Suspension of Ampicillin and Amiloride Hcl
Hydrochlorothiazide Tablets. The agreement requires expert
certifications to be submitted and approved by FDA prior to
reentering the market for these products. Shipments of all other
forms of Amoxicillin and all other Biocraft products are expected
to continue uninterrupted.
There are no critical health or safety issues associated
with these products or any other Biocraft products on the market.
In signing the agreement, the Company does not admit any
wrongdoing, but rather seeks to resolve FDA's concerns by having
independent experts certify as to the validity of certain
manufacturing procedures and testing methodology. The Company
also expects to recall select product lots. Given the relatively
narrow scope of the recalls, the Company does not expect it to
materially affect its financial condition.
"This is a step toward a more regular relationship with the
FDA," said Harold Snyder, President and Chief Executive Officer.
"If the FDA is satisfied with the expert certifications on these
and other products, to be completed within four months or less,
we believe that our new drug applications will be back on track
to proceed through the FDA approval process. Our customers,
shareholders and suppliers should be reassured by this agreement
because it involves specific issues that can be resolved and the
products directly affected are limited. Our customers can
continue to use our products with confidence."
The agreement with the FDA requires certification of
procedures used in the manufacture and testing of other drugs
under a schedule, but the Company expects to be able to resolve
those matters without any disruption in shipping. The Company's
bulk pharmaceutical manufacturing operations are not affected by
this agreement.
Although the Company has not completed its financial results
for the quarter ended June 30, 1994, it currently expects to
reflect a loss. Costs related to FDA issues, including expert
and attorney's fees and diversion of the Company's manufacturing
and laboratory resources, account, in part, for the disappointing
results.
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