USFDA Flags Major Manufacturing Lapses at Zydus Lifesciences

The US Food and Drug Administration (USFDA) has issued a warning letter to Zydus Lifesciences for significant violations of good manufacturing practices at their Gujarat facility. The letter points out the company's failure to address contamination issues, including glass particulate contamination in multiple batches of Cyanocobalamin Injection.

The US health regulator has raised concerns over Zydus Lifesciences for lapses in manufacturing at its Gujarat-based plant.

In a warning letter addressed to the company's Managing Director, Sharvil Patel, the US Food and Drug Administration (USFDA) highlighted that the drug maker failed to investigate contamination identified in products at its Vadodara district plant.

The facility was inspected from April 15 to 23, 2024, revealing significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.

According to the USFDA, Zydus Lifesciences' methods, facilities, or controls were not in conformity with CGMP regulations, rendering their drug products adulterated.

The USFDA inspection found that the firm did not thoroughly investigate unexplained discrepancies or batch failures, resulting in multiple cross-contamination events over three months.

The warning letter also noted the inadequacy in addressing glass particulate contamination in Cyanocobalamin Injection batches.

USFDA demanded a detailed remediation plan with timelines to address the contamination risks from the company.

The regulator suggested the company engage a consultant to meet CGMP requirements and warned that it might withhold approval for new applications until compliance is guaranteed.

Zydus Lifesciences was given 15 working days to respond with their corrective actions and measures to prevent recurrence of the deviations.

FDA further stated it would verify the corrective actions through re-inspection.

(With inputs from agencies.)