For about three months, there were multiple cross-contamination events at the facility, he said | Photo: X@ZydusUniverse
The US health regulator has stopped Zydus Lifesciences for manufacturing lapses at its Gujarat plant.
In a warning letter to the company’s managing director Sharvil Patel, the US Food and Drug Administration (USFDA) said the drugmaker failed to investigate contamination identified in pharmaceutical products at its Jarod plant in Vadodara district.
The FDA said it inspected the manufacturing facility from April 15 to April 23, 2024.
“This warning letter summarizes significant violations of current good manufacturing practice (CGMP) standards for finished pharmaceutical products,” he added.
He added: “Because their manufacturing, processing, packaging or storage methods, facilities or controls do not conform to good manufacturing practices (CGMP), their pharmaceutical products are adulterated.”
A warning letter is issued when the U.S. health regulator finds that a manufacturer has significantly violated its regulations.
Elaborating on manufacturing issues at the facility, the USFDA noted: “Your company failed to thoroughly investigate any unexplained discrepancies or failures of a batch or any of its components to meet any of its specifications, regardless of whether the batch has been distributed or not.”
For approximately three months, there were multiple events of cross-contamination at the facility, he said.
“Their investigation failed to consider all affected lots, all manufacturing equipment involved, and the adequacy of the testing methods used to release contaminated drug products,” the USFDA said.
The U.S. health regulator also said the company failed to adequately investigate and determine the root cause of glass particle contamination in several lots of cyanocobalamin injection (USP 1000 mcg/mL, 1 mL).
“Your company failed to establish and follow appropriate written procedures designed to prevent microbiological contamination of pharmaceutical products claimed to be sterile, including validation of all aseptic and sterilization processes,” it added.
The FDA has asked the pharmaceutical company for a detailed remediation plan with timelines to address the findings of the contamination risk assessment.
“Given the nature of the violations we identified at your company, you should engage a consultant… to assist your company in meeting CGMP requirements,” he added.
The USFDA may withhold approval of new applications or supplements that list the company as a drug manufacturer until deviations have been fully addressed and compliance with CGMP is confirmed.
“We may reinspect to verify that you have completed corrective actions for any deviations,” the USFDA said.
It also stated: “After receiving this letter, please respond to this office in writing within 15 business days. Please specify what you have done to correct the deviations and prevent their recurrence.”
The warning letter issued by the U.S. FDA typically identifies the violation, such as poor manufacturing practices, problems with claims about what a product can do, or incorrect instructions for use.
The letter also makes clear that the company must correct the problem and provide instructions and a timeline of its plans for correction.
The FDA then verifies that the company’s corrections are adequate.
(Only the headline and image of this report may have been reworked by Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
First published: September 15, 2024 | 11:58 am IS
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