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# Zydus India Plant Cited After FDA Inspection
- URL: https://www.fdaweb.com/zydus-india-plant-cited-after-fda-inspection/
- Published: 2026-02-13T12:00:00.000Z
- Updated: 2026-09-14T13:33:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160672

FDA has cited Zydus Lifesciences’ sterile drug manufacturing facility in Vadodara, India, for significant quality control and aseptic processing deficiencies following an inspection conducted in September. In a [just-posted Form FDA 483](https://www.fda.gov/media/191121/download?ref=fdaweb.com), 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.

The inspection further identified deficiencies in cleaning and disinfection practices for aseptic filling lines, including lack of defined cleaning sequences, pooling of disinfectant solutions in hard-to-reach areas, and inadequate procedural controls to ensure sterile conditions. Investigators observed operators using the same mop head across multiple surfaces without a top-to-bottom cleaning order and noted insufficient documentation of environmental monitoring data within the firm’s electronic quality system.

Additional concerns were raised regarding the adequacy of non-viable particle monitoring protocols, including a lack of evidence that probe placement and operating conditions during qualification studies represented worst-case commercial manufacturing scenarios.