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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ) -- Ignore unavailable to you. Want to Upgrade?

To: jack w garnes jr. who wrote (3038)	12/5/1997 5:52:00 PM
From: wombat	Read Replies (2) \| Respond to of 23519

Jack: Did the company ever get this mess cleaned up? The Company's New Jersey manufacturing facility at Paco Pharmaceutical Services, Inc. ("Paco") was inspected by the FDA for the first time after the pre-approval inspection during twelve days in February and March 1997. That inspection resulted in the issuance by the FDA of an extensive FDA Form 483, which detailed specific areas where the FDA inspector observed that the Company's operations were not in full compliance with some areas of the current Good Manufacturing Practices ("cGMP") regulations. A corrective action plan addressing all identified cGMP deficiencies was initiated immediately, and the Company submitted a written response to the FDA Form 483 and requested a meeting with the FDA District Office officials to address the matter. Approximately 30 days after submitting the initial written response, the Company provided the FDA with a written update of the progress made against the corrective action plan. The Company provided an additional written response to comments and questions from the FDA in April and May 1997. Following a meeting with FDA officials on May 23, 1997, the FDA issued a Warning Letter to the Company on May 29, 1997 reiterating the deficiencies noted in the earlier FDA Form 483. The Company's manufacturing facility was reinspected by the FDA during seven days in August and September 1997. That reinspection resulted in the issuance of an FDA Form 483, which mentioned specific areas cited in the earlier Form 483, where the FDA inspector continued to observe that the Company's operations were still not in full compliance with some areas of the cGMP regulations. On September 18, 1997, the Company provided a written response and requested that the FDA affirm that the Company's New Jersey manufacturing facility is in substantial compliance with cGMPs. Continued failure to adequately address cGMP deficiencies within a reasonable time frame or to comply with cGMP regulations would have an adverse effect on the Company's ability to supply its product in the US and internationally, which would have a material adverse effect on the Company's business, financial condition and results of operations. There can be no assurance that the FDA will deem the Company's corrective action or written response to the Form 483 observations to be adequate or that additional corrective action will not be required. Failure to achieve and maintain satisfactory cGMP compliance could have a material adverse effect on the Company's ability to continue to market and distribute its products and, in the most serious cases, could result in the issuance of additional Warning Letters, seizure or recall of products, civil fines or closure of the Company's New Jersey manufacturing facility until cGMP compliance is achieved.