FDA EIR - Alcami Carolinas Corporation - October 04, 2024

An FDA surveillance inspection of Alcami Carolinas Corporation's St. Louis, MO, contract testing laboratory for human and veterinary drugs occurred from October 1 to October 4, 2024. This comprehensive cGMP inspection, conducted under regulatory guidelines for drug manufacturing (CP 7356.002, CP 7371.001), revealed significant deficiencies, resulting in a two-item FDA Form 483. The main violations centered on inadequate quality control unit procedures, specifically concerning electronic data integrity and microbiological testing. Observations included a lack of controls to prevent data modification, deletion, or alteration for laboratory instruments, such as a refractometer lacking audit trail review and another system storing raw data on an unprotected local drive (violating 21 CFR 211.22(d)). Additionally, the facility failed to adequately record and investigate discrepancies in microbiological testing results. The inspection also noted deficiencies in the investigation process, trending analyses, and the implementation of corrective and preventative actions (CAPAs), particularly regarding recurring issues attributed to human error without documented corrective measures for analysts. Management was informed of potential penalties under the Federal Food, Drug, and Cosmetic Act and committed to submitting a written response detailing their corrective actions within 15 business days.