FDA 483 - Intas Pharmaceuticals Limited - February 14, 2025

An FDA inspection of Intas Pharmaceuticals Limited in Ahmedabad, Gujarat, India, conducted from February 3-14, 2025, revealed significant and repeat deficiencies in the company's adherence to Good Manufacturing Practices (GMP) for drug substance and drug product manufacturing. Key violations include a lack of adequate written procedures for production and process controls, notably insufficient scientific justification for in-process sampling frequencies. Critical shortcomings were identified in procedures designed to prevent microbial contamination of sterile drug products, involving open processing, improper material handling, operator aseptic technique, environmental monitoring, cleaning and disinfection practices, and inadequacies in smoke studies. The facility itself showed poor maintenance, with issues like cracked surfaces, residue, and chipped infrastructure across manufacturing, utility, and laboratory areas. Furthermore, the Quality Unit exhibited insufficient oversight, evidenced by inappropriate endotoxin acceptance criteria, a lack of tracking for pending laboratory samples, and inadequate Continued Process Verification. Several Standard Operating Procedures were found to be deficient or not consistently followed, particularly concerning stability studies, cross-contamination prevention, testing procedures, and personnel training. Intas Pharmaceuticals Limited is required to submit a detailed response outlining corrective and preventive actions to address these serious observations and ensure full compliance with cGMP regulations.