FDA 483 - Alcami Carolinas Corporation - October 04, 2024

Alcami Carolinas Corporation, a contract laboratory in St Louis, MO, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate quality control unit procedures, including a lack of data integrity controls for electronic records and raw data, and a failure to investigate microbiological testing discrepancies. Additionally, the firm failed to thoroughly review unexplained discrepancies, lacked statistical rationale for trend investigations, and did not implement adequate corrective actions for recurring analyst errors.