Zydus Lifesciences 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 adequately investigate contamination identified in your drug products. Cross-contamination Over approximately 3 months, you experienced multiple cross-contamination events. Your firm identified cross-contamination from (b)(4) drug product…

Your firm failed to establish adequate written procedures for production and process control designed to assure that drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and to follow all of your written production and process control procedures (21 CFR 211.100 (a) and 211.100 (b). Your process performance qualifications (PPQ) lack adequate supporting data to assess variability in your manufacturing…

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)). You failed to ensure adequate aseptic behavior and adequate airflow simulations to prevent potential contamination. Poor Aseptic Behavior Our investigators observed multiple instances of poor aseptic techniques…