The US health regulator has pulled up Intas Pharmaceuticals for manufacturing lapses, including violation of current good manufacturing practice (CGMP) regulation, at its Ahmedabad-based plant.
The USFDA noted that in a previous inspection, including the inspection of July 22 to August 2, 2019, FDA had cited similar CGMP observations
The US health regulator has pulled up Intas Pharmaceuticals for manufacturing lapses, including violation of current good manufacturing practice (CGMP) regulation, at its Ahmedabad-based plant.
In a warning letter to the company's CEO and MD Nimish Chudgar, the US Food and Drug Administration (USFDA) has pointed out various manufacturing lapses at the Matoda-Sanand, Ahmedabad-based facility.
A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations.
The USFDA inspected the facility from May 1-12, 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 warning letter, the health regulator pointed out the company "failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity".
It also noted that the company's Quality Assurance (QA) and production departments failed to provide adequate oversight and ensure the reliability of data related to the quality of finished drug products manufactured 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.
More specifically, the investigation found that operators manipulated the defect quantities "to keep the category wise rejections within limits to avoid a deviation and investigation," it added.
The US health regulator also pointed out that the company 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.
Besides, 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 US health regulator further pointed out that the company failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products.
The USFDA noted that in a previous inspection, including the inspection of July 22 to August 2, 2019, FDA had cited similar CGMP observations.
"Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate," it added.
Significant findings in the letter demonstrate that the company does not operate an effective quality system in accord with CGMP, the USFDA stated.
It further said, "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."
Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at the plant, it added.