FDA 483 - Industria Farmaceutica Galenica Senese Srl - July 01, 2022

An FDA inspection of Industria Farmaceutica Galenica Senese Srl in Monteroni D'Arbia, Siena, revealed significant deficiencies in quality control and record-keeping. The firm failed to adequately investigate out-of-specification results and lacked complete master production and control records. These issues indicate a need for improved quality system oversight.