International Trading Pharm Lab Inc – FDA Warning Letter, Oct 29, 2019

The FDA issued a Warning Letter to International Trading Pharmaceuticals Laboratories, Inc. (ITPL) following an October 2019 inspection, citing significant deviations from current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (API). The inspected API are deemed adulterated under 21 U.S.C. 351(a)(2)(B). The firm's response to the FDA 483 was inadequate. Key violations include the quality unit's failure to ensure appropriate drug testing and reporting, specifically regarding oversight of out-of-specification (OOS) investigations, unreported re-injections, and experimental data. ITPL also failed to establish and follow written procedures for investigating critical deviations, closing OOS results without adequate scientific justification, such as lacking solution stability data for aged samples. Furthermore, the firm did not verify the suitability of analytical methods used for drug samples and lacked sufficient controls over computerized systems (HPLC/GC) to prevent unauthorized data access or changes, with audit trails not enabled. The FDA strongly recommended retaining a qualified consultant for remediation. ITPL must provide comprehensive assessments, remediation plans, and updated procedures for data integrity, OOS investigations, method verification, and quality unit oversight within 15 working days to avoid further legal action or impact on drug approvals.