USFDA cites manufacturing lapses at Zydus Lifesciences' Gujarat plant

The US health regulator has pulled up Zydus Lifesciences for manufacturing lapses at its Gujarat-based plant.

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

The USFDA said it inspected the manufacturing facility from April 15 to 23, 2024.

"This warning letter summarises significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals," it added.

It further said: "Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated."

A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations.

 

Elaborating on the manufacturing issues at the facility, USFDA noted: "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."

For around three months, there were multiple cross-contamination events at the facility, it said.

"Your investigation failed to consider all impacted batches, all manufacturing equipment involved, and the adequacy of your testing methods used to release contaminated drug products," USFDA noted.

The US health regulator also pointed out that the company failed to adequately investigate and determine the root cause of glass particulate contamination in multiple batches of Cyanocobalamin Injection (USP 1000mcg/mL, 1mL).

"Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilisation processes," it added.

USFDA sought a detailed remediation plan from the drug firm with timelines to address the findings of the contamination hazards risk assessment.

"Based upon the nature of the violations we identified at your firm, you should engage a consultant... to assist your firm in meeting CGMP requirements," it added.

USFDA may withhold approval of new applications or supplements listing the company as a drug manufacturer until deviations are completely addressed and it confirms compliance with CGMP.

"We may re-inspect to verify that you have completed corrective actions to any deviations," USFDA said.

It further stated: "After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any deviations and to prevent their recurrence."

The warning letter issued by the USFDA usually identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use.

The letter also makes clear that the company must correct the problem and provide directions and a timeframe of its plans for correction.

FDA then checks to ensure that the company's corrections are adequate.