483
Societal CDMO Gainesville, LLCSocietal CDMO Gainesville, LLC – FDA 483, Aug 12, 2019
Record Details
An FDA inspection of Recro Gainesville LLC, a drug manufacturer in Gainesville, GA, revealed significant deficiencies in laboratory record-keeping and the quality control unit's investigation processes. Specifically, the firm failed to maintain complete analytical data and adequately investigate non-conformances and out-of-specification results. These issues indicate a lack of robust quality assurance and data integrity practices.
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ID · 44334b9e-433a-42ea-8b7b-ff4347c8ee71
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