-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Cv2favhnVmKVAOqUcP8o7uwHDvnJL7lX5oVuxxGBJE8tVfNDCjnN1j+eLbFPJfXM QxzRCHTn3nbx6qZQvOg8Zg== 0000950130-97-001635.txt : 19970411 0000950130-97-001635.hdr.sgml : 19970411 ACCESSION NUMBER: 0000950130-97-001635 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 19970409 ITEM INFORMATION: Acquisition or disposition of assets FILED AS OF DATE: 19970410 SROS: NASD FILER: COMPANY DATA: COMPANY CONFORMED NAME: ROBERTS PHARMACEUTICAL CORP CENTRAL INDEX KEY: 0000853022 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 222429994 STATE OF INCORPORATION: NJ FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-19173 FILM NUMBER: 97577686 BUSINESS ADDRESS: STREET 1: MERIDIAN CENTRE II STREET 2: 4 INDUSTRIAL WAY W CITY: EATONTOWN STATE: NJ ZIP: 07724 BUSINESS PHONE: 9083891182 MAIL ADDRESS: STREET 1: MERIDIAN CTR II STREET 2: 4 INDUSTRIAL WAY WEST CITY: EATONTOWN STATE: NJ ZIP: 07724 8-K 1 FORM 8-K 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 - -------------------------------------------------------------------------------- (exact name of registrant as specified in its charter) New Jersey 1-1-432 22-2429994 - ---------------- ------------- --------------- (State or other (Commission (IRS Employer jurisdiction of File Number) Identification incorporation) Number) Meridian Center II 4 Industrial Way West Eatontown, New Jersey 07724 - -------------------------------------------------------------------------------- (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 - -------------------------------------------------------------------------------- (Former name or former address, if changed from last report) -2- Item 5. Other Events ------------ 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 --------------------------------- (Registrant) /s/ Anthony A. Rascio Date: April 10, 1997 --------------------------------- Anthony A. Rascio Vice President -----END PRIVACY-ENHANCED MESSAGE-----