The pharma major, Zydus Lifesciences Ltd on 16 September announced that the US Food and Drug Administration (USFDA) has issued a warning letter for its Gujarat -based plant. 

In its regulatory filing, the company said that the US regulator has issued a warning letter to the company stating that they have failed to investigate contamination identified in drug products at its Jarod plant in Vadodara district. 

The USFDA has conducted an inspection of the facility between 15 April and 23 April. 

The company added, “This warning letter summarises significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.”

The warning letter stated, “Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated.”

The US health regulator issues a warning letter when they find that the manufacturer has significantly violated its regulations. 

The USFDA added, “Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed.”

The company has failed to adequately investigate and determine the main cause of glass particulate contamination in multiple batches of Cyanocobalamin Injection (USP 1000 mcg/mL, 1mL).

The company has been asked to submit a detailed remediation plan, including timelines to address the findings of the contamination hazards risk assessment.

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