FDA EIR - Infinity Laboratories LLC - January 07, 2021

An FDA inspection of Infinity Laboratories LLC, a contract testing laboratory located in Castle Rock, CO, was conducted from January 5-7, 2021. The inspection, guided by CPGM 7356.002 (Drug Manufacturing Inspections) and the Guide to Inspections of Pharmaceutical Quality Control Laboratories, identified several areas of non-compliance with Good Manufacturing Practices (GMP). Key violations noted included insufficient investigation into unexplained discrepancies (21 CFR 211.192), specifically concerning inadequate root cause analysis for Out-of-Specification (OOS) results in chemical assays and sterility analyses. The firm also lacked a comprehensive data integrity program, with the Quality Unit failing to routinely review electronic raw data, audit trails, and metadata to ensure completeness and accuracy (21 CFR 211.194(a)). Furthermore, procedures for environmental air monitoring during sterility analysis did not include limits for exposure duration to ensure the growth-supporting capability of media (21 CFR 211.160(b)(2)). Lastly, specific temperature-sensitive laboratory equipment was not regularly calibrated for accuracy (21 CFR 211.160(b)(4)). An FDA-483 was issued. Management committed to implementing appropriate corrections and providing a written response to the FDA within 15 working days, with one observation related to environmental monitoring procedures rectified during the inspection.