FDA 483 - Societal CDMO Gainesville, LLC - August 12, 2019

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.