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Executive Summary

Warner-Lambert has revamped its Puerto Rico operations quality assurance unit in the wake of compliance problems at its two Puerto Rico pharmaceutical production facilities. The problems were uncovered by FDA inspectors during a series of five inspections over the last year and several in 1991. The agency's observations include: the company's failure to properly document unfavorable test results for certain products, stability and potency problems, inadequate investigation of medical complaints, failure to report process changes and product contamination. In a Nov. 24 response to the latest round of "observations," resulting from a November agency inspection of W-L's Vega Baja, P.R. facility, Warner-Lambert Worldwide Regulatory Affairs Senior VP W.M. Merino said the company is making "good faith efforts" to address the agency's concerns. "Top corporate management has made it clear that all necessary resources will be provided." The Puerto Rico quality assurance unit "has in fact been revamped from top to bottom," Merino noted. "New management of the quality functions is in place and a major reorganization is under way to improve quality support operations." In addition, "extensive new GMP/GLP training is being provided." The company has hired an outside consultant to conduct an audit of its products. Merino added that the company has withdrawn several NDAs at the request of FDA "because of concerns over included in annual reports." During 1992, FDA has conducted three inspections of Warner- Lambert's Vega Baja, P.R. facility and two inspections of its Fajardo, P.R. plant. The inspections have resulted in over 130 observations regarding Good Manufacturing Practices regulations and record-keeping. FDA also conducted several inspections of the facilities from May through December 1991. An FD-483 inspection report, issued following the Nov. 2-20 Vega Baja inspection, notes that Warner-Lambert "failed to revalidate manufacturing processes after it was discovered during 1991 that analytical test results were not always" within specifications. "Currently, because of lack of adequate revalidation there is no assurance how many products can meet all production and quality attributes," the report adds. The report states that, prior to 1991, "FDA was not notified about problems with the analysis, stability, manufacture or quality of the 16 [prescription] products" being manufactured at the Vega Baja plant. Following a December 1991 inspection, Warner- Lambert halted manufacture of five of the 16 products, including the thyroid hormones Euthroid and Proloid for failure to meet potency specifications; Easprin (aspirin delayed release) for dissolution problems; the urinary tract analgesic Pyridium Plus because of inconsistent assay results. In addition, Ergostat (ergotamine) and Parsidol samples failed stability testing, the report mentions. Warner-Lambert issued recalls for certain lots of Euthroid, Proloid and Easprin in June and July 1992. Warner-Lambert acknowledged "record-keeping" problems at its two P.R. facilities in a September 10Q filing with the Securities and Exchange Commission ("The Pink Sheet" Nov. 30, p. 3). The record-keeping problems do not involve batch records. The firm said it is conducting validity assessments for all of the products manufactured by the plants. The November Vega Baja report, as well as a Nov. 19 FD-483 for the Fajardo plant, maintain that W-L investigations of medical complaints relating to subpotency for such products as the anti- epileptic Dilantin Kapseals (phenytoin), Nitrostat (nitroglycerin), Procan SR (procainamide), Pyridium and Lopid (gemfibrozil) were "inadequate" and "not always conducted in a timely manner." Among manufacturing problems noted in the reports are the detection of microbial contamination and metal particles in such products as Lopid as late as July and August 1992. "From June through October 1992, at least 21 Discrepancy Reports were issued for metal contamination of different products in different stages of processing," a November report states. "Falling screws and printer parts, as well as scraps resulting from equipment malfunction are examples of the sources of contamination documented."

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