FDA 483 - Industria Farmaceutica Galenica Senese Srl

The FDA inspection of Industria Farmaceutica Galencia Senese SRL in Monteroni D'Arbia, Siena, Italy, revealed significant deficiencies across multiple areas of sterile drug product manufacturing. Key issues included a lack of consistency and reproducibility in injection batch production, incomplete stability records, and inadequate investigations into out-of-specification results. The firm also failed to establish proper controls for microbiological contamination, maintain environmental monitoring, and ensure adequate equipment calibration and temperature/humidity control, indicating a serious lack of quality assurance.