FDA WARNING_LETTER - Indiana Chem-Port - August 07, 2021

The FDA inspected Indiana Chem-Port's drug manufacturing facility in India from August 2-7, 2021, identifying significant deviations from current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (API), rendering their drugs adulterated per 21 U.S.C. 351(a)(2)(B). Key violations included failure to ensure equipment surfaces in contact with API do not alter quality, evidenced by rust and improper repairs. The firm also failed to validate manufacturing processes and adequately validate cleaning procedures for non-dedicated equipment, raising cross-contamination risks. A documented, ongoing stability testing program for API was lacking, and the Quality Unit was found to be neither independent nor effective, exhibiting poor documentation practices like torn logbook pages and destroyed batch records. Furthermore, the quality system inadequately ensured data accuracy and integrity. The company also failed to fulfill annual drug establishment registration requirements (21 U.S.C. § 360(i)(1)) and properly list drugs for U.S. commercial distribution, resulting in misbranded products. The FDA strongly recommended retaining a qualified consultant to assist with remediation. Corrective actions, including comprehensive CAPA plans for all deficiencies, are required within 15 working days. Non-compliance has led to Import Alert 66-40 and may result in withheld approvals and continued refusal of admission for products into the U.S.