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FORM 8-K
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
April 9, 1997
ROBERTS PHARMACEUTICAL CORPORATION
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(exact name of registrant as specified in its charter)
New Jersey 1-1-432 22-2429994
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(State or other (Commission (IRS Employer
jurisdiction of File Number) Identification
incorporation) Number)
Meridian Center II
4 Industrial Way West
Eatontown, New Jersey 07724
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(Address of principal executive offices, including zip code)
Registrant's telephone number, including area code: 908-389-1182
Meridian Center II
4 Industrial Way West
Eatontown, New Jersey 07724
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(Former name or former address, if changed from last report)
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Item 5. Other Events
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Roberts Pharmaceutical Corporation announced today it has responded to
a FORM FDA 483 issued November 18, 1996 citing certain deficiencies following a
routine inspection of its Eatontown facility, where there are no
manufacturing or quality control operations. Roberts anticipates near-term
receipt of an FDA letter indicating that the Company's written reply to FORM FDA
483 was satisfactory.
The FDA raised questions about documentation and stability dates for
certain batches of a topical medicine, Topicycline and the Company noted that:
1) all appropriate tests were done; 2) the tested lots complied with
specifications; and 3) no product recall was requested by the agency. The
Company further notes that written procedures do exist concerning quality
control (QC) and that QC responsibilities are being formalized in a written
document. Roberts also indicated that it does have a system for evaluating the
quality of drug products.
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.
ROBERTS PHARMACEUTICAL CORPORATION
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(Registrant)
/s/ Anthony A. Rascio
Date: April 10, 1997 ---------------------------------
Anthony A. Rascio
Vice President
