USFDA Warns Zydus Lifesciences for Manufacturing Violations

16 Sep 2024 , 03:43 PM

The US Food and Drug Administration (USFDA) has issued a warning letter to Zydus Lifesciences regarding manufacturing deficiencies at its Gujarat-based plant.

The USFDA’s inspection of the facility took place from April 15 to 23, 2024, uncovering significant breaches of current good manufacturing practices (CGMP).

The warning letter specifically cites Zydus’s failure to properly investigate contamination issues in drug products at its Jarod plant in Vadodara district.

The USFDA identified multiple instances of cross-contamination at the facility and noted that the company did not adequately address these issues. Zydus Lifesciences was found to have not thoroughly investigated discrepancies or failures in drug batches, including those already distributed.

The USFDA highlighted that the company did not consider all affected batches, manufacturing equipment, or the adequacy of testing methods used to release contaminated products.

The regulator pointed out that Zydus failed to determine the root cause of glass particulate contamination in multiple batches of Cyanocobalamin Injection (USP 1000mcg/mL, 1mL). The company also did not establish or follow proper written procedures to prevent microbiological contamination of sterile drug products, including validation of aseptic and sterilization processes.

The USFDA has requested a comprehensive remediation plan with specific timelines from Zydus to address the contamination issues and improve compliance.

Until the company addresses these deviations and demonstrates compliance with CGMP, the USFDA may withhold approval of new drug applications or supplements listing Zydus as a manufacturer.

Zydus Lifesciences is required to respond in writing within 15 working days, detailing the actions taken to rectify the issues and prevent future occurrences. The USFDA may conduct a follow-up inspection to verify that the corrective actions have been implemented effectively.