FDA WARNING_LETTER - Indoco Remedies Limited - July 26, 2024

The FDA issued a Warning Letter to Indoco Remedies Limited following an inspection from July 16 to 26, 2024, at their Goa, India facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). The firm's August 15, 2024 response to the FDA 483 was deemed inadequate. Key violations include failure to record and justify deviations from required laboratory control mechanisms (21 CFR 211.160(a)), particularly concerning microbiological testing reliability. The firm also failed to establish and follow appropriate written procedures to prevent microbiological contamination of sterile drug products, including validation of aseptic processes (21 CFR 211.113(b)), evidenced by inadequate airflow studies. Deficiencies were noted in maintaining equipment for aseptic conditions (21 CFR 211.42(c)(10)(vi)), with unsuitable conditions in ISO 5 areas. Furthermore, the firm failed to thoroughly investigate unexplained discrepancies or batch failures (21 CFR 211.192), with complaint investigations relying on flawed analyses. Finally, an inadequate quality unit was identified, with responsibilities not fully followed, particularly concerning the review of chromatography data software audit trails (21 CFR 211.22(a) and 211.22(d)). These are repeat violations from a 2023 inspection, indicating inadequate executive management oversight and an ineffective quality system. The FDA recommends engaging a qualified CGMP consultant (21 CFR 211.34). The firm must promptly correct all violations, as failure to do so may result in the FDA withholding approval of new applications, re-inspection, and refusal of admission of products into the U.S. A written response detailing corrective actions is required within 15 working days.