Intas Pharmaceuticals Limited — FDA Warning Letter Findings

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). You failed to initiate or conduct adequate investigations into significant deviations in your aseptic processing manufacturing operations. You lacked investigations into visual inspection failures and non-viable particulates (NVP) exceeding your action…

Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113 (b)). A. Your procedures did not include a requirement for smoke studies to be performed in dynamic conditions in classified critical areas. There have been no smoke studies to determine whether the “ (b)(4) LAF…

Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess (21 CFR 211.100 (a)). Your personnel qualification for the visual inspection of injectable products is deficient. A. Your firm failed to provide adequate challenge test set vials to qualify your operators to perform the visual inspection of…

Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). Your Quality Assurance (QA) and production departments failed to provide adequate oversight and ensure the reliability of data related to the quality of finished drug products manufactured at your facility. Since 2021, visual inspectors…