Cipla Limited — FDA Warning Letter Findings

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)). Media Fill Contamination Incidents You failed to appropriately evaluate a pattern of media fill failures in your facility and afford sufficient attention to potential correlations among these contamination events…

Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures (21 CFR 211.22(d)). Your QU failed to provide adequate oversight for the retention of original CGMP records. For example, our investigator observed a truck loaded with bags of scrap from Unit (b)(4) , as well as bags stored at a central scrapyard intended for shredding. The bags of scrap included, but were not limited to…

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). Your investigations into quality defect complaints of Albuterol Sulfate Inhalation Aerosol were inadequate because they lacked appropriate and timely corrective actions and preventive actions (CAPAs). You also failed to extend your investigations to…