Zydus Life’s Jarod plant gets USFDA warning letter

12 Sep 2024 , 03:28 PM

On August 29, the US Food and Drug Administration (FDA) issued a warning letter to Zydus Lifesciences Ltd.’s medication production facility in Jarod, Gujarat, following an inspection.

The inspection, which took place in April 2024, discovered unsatisfactory Current Good Manufacturing Practices (CGMP), particularly in terms of cross-contamination, particle pollution, and poor aseptic processes. 

Among other observations, the USFDA has noted incorrect investigation of inconsistencies, insufficient washing that results in cross-contamination between drug goods, and insufficient processes to avoid microbial contamination in sterile medications. Additionally, glass particulate contamination was discovered in many batches of Cyanocobalamin Injection.

As per USFDA, the facility did not thoroughly analyse contamination across medicine batches and continued to issue compromised items. Despite efforts to enhance cleaning techniques, cross-contamination continued.

Further, Zydus failed to identify the source of glass particulate contamination in its Cyanocobalamin Injection products, releasing batches that lacked acceptable inspection and operator qualifications.

The US FDA also noticed poor aseptic behaviour, such as operators disrupting sterile settings. The facility’s airflow simulations were insufficient, failing to prevent contamination.

The facility’s process validation lacked comprehensive data, and the FDA found deficiencies in analysing intra- and inter-batch variability.

The USFDA’s letter emphasised that Zydus must take corrective steps to resolve these problems. Failure to comply may result in additional regulatory proceedings, such as the refusal of US imports from the plant. The FDA suggested that Zydus hire a CGMP consultant to assure regulatory compliance.

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