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LILLY RECEIVES 80-PAGE FD-483 FROM FDA

Executive Summary

LILLY RECEIVES 80-PAGE FD-483 FROM FDA on Aug. 26 following a for-cause inspection of the firm's Indianapolis manufacturing facility. The comprehensive inspection was initiated by FDA's Detroit district office in April as a follow-up to a series of recalls conducted by Lilly involving products that had failed routine stability testing. The firm's formulation and process validation procedures were key areas of FDA concern on the FD-483 adverse findings report issued the firm at the conclusion of the inspection. According to FDA, the Lilly inspection was in no way connected with the ongoing generic investigations. An FDA field official noted that the Lilly inspection was, in fact, delayed due to the need for channeling field personnel to meet the generic investigation needs. The inspection was precipitated by Lilly's recalls of Axid (nizatidine) capsules in May 1988, and of Darvon (propoxyphene HCl) capsules the following month. Both of the recalls involved failure of the products to meet dissolution specifications during routine stability testing. Lilly also had conducted a recall of Darvon pulvules for the same reason in 1987. Since the FDA inspection began, Lilly has conducted two other recalls involving products with stability problems. A recall of Lilly's brand of immediate action and enteric coated prescription thyroid tablets was initiated by the firm June 22 based on stability studies finding that the potency of the products was not assured through the expiration period (see FDA's "Enforcement Report," following item). Lack of validation of the process used for manufacturing the thyroid products was among the adverse findings listed on the FD-483 issued to Lilly. A recall of all marketed lots of 11 vitamin and mineral products was initiated by the firm a week later (June 30), also based on adverse stability test findings. According to FDA, Lilly has ceased distribution of the recalled vitamin and mineral products as well as the thyroid tablets.
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