FDA 483 - Zydus Lifesciences Limited - August 25, 2025

An FDA inspection conducted at Zydus Lifesciences Limited, a sterile drug product manufacturer in Vadodara, Gujarat, India, from August 25, 2025, to September 5, 2025, identified significant deviations from regulatory expectations, documented in an FDA Form 483. The inspection revealed critical issues impacting quality and control.

Specifically, the firm failed to adequately investigate over 100 instances of microbial contamination from environmental and personnel monitoring, often classifying them as "isolated incidents" without thorough root cause analysis. Investigations into out-of-specification and out-of-trend analytical results were also deemed insufficient, with concerns regarding the scientific justification for invalidating initial results and subsequent retesting.

Furthermore, aseptic processing areas exhibited deficiencies in cleaning and disinfection procedures, including a lack of sequential steps, improper application of disinfectants, and ineffective cleaning techniques that led to solution pooling. The laboratory control mechanisms were compromised, as the LIMS system allowed "Administrator" and "Approver" roles the privilege to alter critical environmental monitoring data, raising concerns about data integrity. Lastly, the protocol for monitoring non-viable particle counts in aseptic filling lines was found inadequate, lacking defined probe orientations and failing to represent worst-case manufacturing conditions.

Zydus Lifesciences Limited is required to provide a comprehensive response detailing corrective and preventive actions to address these serious observations and ensure compliance with good manufacturing practices.