FDA EIR - Zydus Lifesciences Limited - April 23, 2024

An unannounced FDA Good Manufacturing Practice (GMP) inspection of Zydus Lifesciences Limited in Jarod, India, was conducted from April 15-23, 2024. The inspection, focusing on sterile drug product manufacturing for the U.S. market under compliance program 7356.002A, aimed to assess ongoing adherence to FDA regulations, including evaluation of corrective actions from a prior 2022 inspection. The previous inspection had identified issues related to stability testing, batch record review, and facility maintenance.

The current inspection revealed significant deficiencies, leading to a 10-item FDA Form 483. Main violations included a failure to thoroughly investigate unexplained discrepancies, notably pervasive product cross-contamination due to inadequate equipment cleaning, and recurrent glass particle defects in finished drug products. Inspectors also found that established sampling plans and test procedures were not adhered to, with employees providing false information during interviews regarding sampling records. Critical CCTV systems in manufacturing areas were found to be inoperable and unrecorded for an extended period, despite internal procedures requiring their monitoring. Additional issues encompassed inadequate validation of aseptic processes, deficient environmental monitoring, poor equipment maintenance, and insufficient employee training for assigned functions. Aseptic processing areas showed deficiencies, and appropriate controls over computer systems were lacking.

Firm management committed to correcting all observations and providing an initial written response within 15 business days. The FDA underscored the potential for further regulatory actions if compliance with GMP regulations is not achieved.