Inspection Flags Sterility and Quality Control Concerns at Zydus Lifesciences
FDA has cited multiple manufacturing and quality system deficiencies at a Zydus Lifesciences Limited sterile manufacturing facility in Ahmedabad, Gujarat, India, including concerns related to aseptic processing controls, environmental monitoring, airflow studies and data review procedures, according to a just -posted FDA Form 483 issued following a 4/25-5/5 inspection.
The inspection noted seven observations, several of which focused on potential weaknesses in controls intended to prevent microbial contamination of sterile drug products, according to the 483. FDA stated that the company failed to thoroughly review unexplained discrepancies, regardless of whether affected batches had already been distributed. Investigators cited concerns involving the distance between the work surface and HEPA filters in a critical aseptic filling area, noting that the configuration was not defined during equipment qualification studies.
FDA investigators also cited electronic data integrity concerns. The 483 stated that Zydus had not established procedures for reviewing electronic data prior to batch release. Investigators noted that critical process equipment data, including information from computerized systems, was not routinely reviewed as part of batch record assessment.
Another observation stated that procedures designed to prevent microbiological contamination of sterile drug products were not adequately established, written and followed. FDA specifically cited deficiencies involving controls intended to ensure sterility of products manufactured on a filling line.
Additionally, the agency stated that the firm failed to establish adequate written procedures for production and process controls designed to ensure drug products meet identity, strength, quality and purity requirements. FDA cited concerns with an airflow visualization study performed in March and April 2025, stating that the study was not conducted in accordance with the firm’s protocol and that acceptance criteria related to aseptic filling line testing were insufficient.
The agency further noted that procedures designed to prevent microbiological contamination did not include adequate validation of sterilization processes.
Earlier this year, FDA cited Zydus Lifesciences’ sterile drug manufacturing facility in Vadodara, India, for significant quality control and aseptic processing deficiencies following an inspection conducted in 9/2025. In a that Form FDA 483, investigators documented failures to adequately investigate microbial contamination events and out-of-specification (OOS) laboratory results tied to sterile injectable products. The agency said the company recorded more than 100 microbial data deviations between 2024 and 2025 but frequently treated excursions as isolated incidents by trending only specific locations rather than assessing broader contamination risks across classified areas and equipment. FDA investigators also cited multiple laboratory investigations in which OOS or out-of-trend assay results were invalidated and retested without conclusive root cause determinations, raising concerns about data integrity and scientific justification for batch disposition decisions.