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Lilly’s “normal” 483

Executive Summary

Lilly receives FDA 483 report "as part of the normal inspection process" for its dry and injectable facilities in Indianapolis. Company says that the outcome of the inspection is not expected to delay the expected fourth quarter launch of the antidepressant Cymbalta, which is manufactured at the dry facility. Inspection ran from May 5-23; the 483 was issued on May 29. Lilly has said that it expects FDA will judge its facilities based on the company's GMP progress rather than its absolute compliance (1"The Pink Sheet" April 28, 2003, p. 31)...
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