Executive Summary

PENNEX MUST CONTRACT PLANT INSPECTIONS FOR NEXT THREE YEARS under terms of a consent decree entered into by the company on July 2. Pennex "shall retain an independent person or persons ...[who] shall inspect no less than two times a year for a period of three years from the date of the entry of this decree, to ensure that [the company's manufacturing] facilities remain in compliance," the consent decree states. The Verona, Pa.-based OTC health and beauty aids manufacturer was charged in a May FDA complaint with violations of Good Manufacturing Practices ("The Pink Sheet" June 1, T&G-4). The action was filed against Pennex shortly before former Akzo/PBI and A.L. Labs exec Jack Van Hulst and William Lyons of the New York investment firm William P. Lyons Co. acquired the company from Dutch parent Medicopharma ("The Pink Sheet" June 8, T&G-3). FDA brought the complaint as the result of an "open" investigation begun by the agency in June 1991 after it learned that Pennex had recalled an OTC liquid antacid for bacterial contamination in 1990 without following proper recall and notification procedures ("The Pink Sheet" July 29, 1991, T&G-13). Pennex reported in a July 8 letter that it has had an expert on board for the past five weeks and the required GMP conformity certification has been submitted to FDA. The agency is expected to reinspect the company's facilities in the near future. Pennex must also validate cleaning procedures for its 15 liquid-filling lines by three consecutive successful validation runs for each of six product groupings. The company said it has completed validation for 11 of the 15 filling lines. Pennex has identified five "problem products" that failed stability testing and is "addressing issues associated with them in an expeditious manner." In addition, the company has five "layered tablet" products which will require three prospective validation batches and three months stability testing before they can be released. Pennex President Jack Van Hulst has brought in new managers to oversee the compliance effort. On July 9, the firm announced that it has appointed former Pharmaceutical Basics Regulatory Affairs Director and Corporate General Counsel Robert Pilson to the newly- created position of VP-compliance.