The U.S. health regulator has issued a warning to Intas Pharmaceuticals, citing manufacturing lapses, including breaches of current good manufacturing practice (CGMP) regulations, at its Ahmedabad-based plant.
In a letter addressed to the company’s CEO and MD, Nimish Chudgar, the U.S. Food and Drug Administration (USFDA) highlighted several shortcomings in manufacturing processes at the Matoda-Sanand facility in Ahmedabad.
A warning letter is issued by the U.S. health regulator when it identifies substantial violations of regulations by a manufacturer. The facility underwent scrutiny by the US Food and Drug Administration (USFDA) from May 1 to May 12, 2023.
“This warning letter summarises significant violations of CGMP regulations for finished pharmaceuticals… Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated,” it noted.
In the admonitory letter, the health regulator highlighted that the company had “neglected its obligation to ensure that the manufactured drug products adhere to Current Good Manufacturing Practice (CGMP) standards and fulfill specified criteria for identity, potency, quality, and purity.”
It was also observed that the Quality Assurance (QA) and production departments of the company fell short in delivering sufficient supervision and guaranteeing the accuracy of data pertaining to the quality of the finalized drug products produced at the facility.
“Since 2021, visual inspectors manipulated particle and other defect counts on manual visual inspection records in many instances, in order to keep the finished product batches within rejection limits,” USFDA said.
In particular, the inquiry revealed that operators manipulated the quantities of defects to ensure that rejections within each category remained within acceptable limits, thereby preventing any deviation that would trigger further investigation.
The U.S. health regulator additionally highlighted the company’s failure to conduct a comprehensive inquiry into any unexplained discrepancies or failures of a batch, including its components, to adhere to specified standards. This obligation applies regardless of whether the batch has already been distributed.
“The company failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess,” USFDA stated.
The U.S. health regulator additionally emphasized that the company neglected to implement and adhere to effective written procedures specifically designed to prevent microbiological contamination of its pharmaceutical products.
The USFDA observed that in a prior inspection, which took place from July 22 to August 2, 2019, similar Current Good Manufacturing Practice (CGMP) observations had been cited by the FDA.
“Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” it added.
The noteworthy revelations in the letter highlight that the company does not uphold an efficient quality system in accordance with Current Good Manufacturing Practice (CGMP), as outlined by the US Food and Drug Administration (USFDA).
“Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP,” it further added.
Neglecting to rectify any infractions may lead to the FDA persisting in its refusal to admit articles produced at the facility.
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Published: 10 Dec 2023, 11:58 AM IST