FDA WARNING_LETTER - Accu Bio-Chem Laboratories LLC - August 31, 2021

The FDA inspected Accu Bio-Chem Laboratories, a contract testing laboratory, from August 24-31, 2021, and found significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211). The drug products tested by Accu Bio-Chem are considered adulterated.

Key violations include: 1. **Inadequate OOS Investigations (21 CFR 211.192):** The firm failed to thoroughly investigate out-of-specification (OOS) results, often retesting new preparations without proper investigation. Their OOS procedure lacked instructions for root cause determination and allowed scientifically unjustified invalidation of results. The FDA requires a retrospective review of all invalidated OOS results for the last three years, including scientific justification and client notifications, and a comprehensive remediation plan for OOS investigation systems. 2. **Failure to Validate Test Methods (21 CFR 211.165(e)):** The firm did not perform method verification to ensure chemical and microbiological test methods were suitable for their intended use across different drug products and formulations. The FDA requires an independent assessment of all chemical and microbiological drug test methods, a plan and timeline for verification/validation, and updated procedures. 3. **Inadequate Computer System Controls (21 CFR 211.68(b)):** Electronic data systems lacked appropriate controls to