ABR Laboratory LLC – FDA Warning Letter, Sep 13, 2024

The FDA inspected ABR Laboratory LLC, a contract testing laboratory, from September 9 to 13, 2024, and identified significant Current Good Manufacturing Practice (CGMP) violations, rendering the drug products tested adulterated. The firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)), specifically noting unsuitable methods for microbial testing of OTC drug products that were not verified against USP methods or demonstrated as suitable. Additionally, the firm failed to thoroughly investigate unexplained discrepancies or failures (21 CFR 211.192), such as uninvestigated out-of-range temperature deviations in a refrigerator storing reference microorganisms. The firm's responses to the FDA 483 were deemed inadequate. FDA emphasized that contract labs are extensions of manufacturers and must comply with CGMP. The letter recommends engaging a CGMP consultant and requires a comprehensive, independent assessment of the firm's deviation investigation system, including a detailed action plan for remediation. Failure to promptly address these violations may lead to regulatory actions, including seizure, injunction, withholding of export certificates, and delays in new application approvals.