FDA WARNING_LETTER - Micro Orgo Chem - April 18, 2024

The FDA inspected Micro Orgo Chem from April 11-18, 2024, identifying significant Current Good Manufacturing Practice (CGMP) deviations for active pharmaceutical ingredients (APIs), rendering them adulterated under 21 U.S.C. 351(a)(2)(B). Key violations include the failure to adequately validate cleaning procedures for non-dedicated equipment, which was also found in disrepair, leading to potential cross-contamination. The firm also failed to demonstrate manufacturing process reproducibility, lacking process performance qualification (PPQ) records, qualified equipment, and validated/verified test methods. An inadequate ongoing stability testing program was noted, with no stability studies conducted for batches, and no stability chambers or reserve samples available. Furthermore, the company failed to prepare, review, and approve manufacturing documents, with undocumented activities, unlabeled drums, and missing original batch records. Finally, the quality unit failed to exercise its responsibilities, neglecting change control, annual product reviews, and proper documentation for raw material release and deviations. Micro Orgo Chem committed to a voluntary recall of all APIs shipped to the U.S. and to cease manufacturing for the U.S. market, deregistering until a new facility is qualified. However, their responses to the Form FDA 483 were deemed inadequate, lacking detailed protocols, impact assessments, and verification activities. The FDA requires comprehensive remediation plans for cleaning validation, process validation, stability programs, documentation systems, and quality unit functions, with a response due within 15 working days. The firm's products were placed on Import Alert 66-40, and FDA may withhold approvals or refuse admission of articles if deficiencies are not fully addressed. A CGMP consultant is strongly recommended.