USFDA issues warning letter to Intas Pharma for manufacturing lapses at Ahmedabad plant

11 Dec 2023 , 02:15 PM

The US Food and Drug Administration has issued a warning to Intas Pharmaceuticals for manufacturing flaws, including violations of current good manufacturing practice (CGMP) regulations, at its Ahmedabad factory.

The US Food and Drug Administration (USFDA) has issued a warning letter to the company’s CEO and MD Nimish Chudgar, citing multiple production flaws at the Matoda-Sanand, Ahmedabad-based factory.

The US health agency discovered that a manufacturer had seriously violated its regulations and hence issued a warning letter.

The said manufacturing facility was under inspection from May 1 to May 12, 2023.

This warning notice outlines severe CGMP breaches for finished medicines. Your drugs are adulterated because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP,’ it stated.

The business failed to fulfill its responsibility to ensure drug products generated comply with CGMP, and meet established specifications for identity, quality, strength, and purity, according to the warning letter.

It further stated that the Quality Assurance (QA) and production departments of the corporation failed to provide proper oversight and ensure the dependability of data relevant to the quality of final medicinal products created at the facility.

According to the report, operators altered the defect numbers to keep the category-wise rejections under limits to prevent deviation and investigation.

The company also failed to adequately analyze any inexplicable disparity or failure of a batch or any of its components to fulfill any of its criteria, whether or not the batch had previously been delivered, according to the US health authorities.

The business also failed to create and execute necessary documented processes aimed at avoiding microbiological contamination of medicinal items, according to the US health authorities.

According to the USFDA, significant findings in the letter indicate the company’s failure to operate an effective quality system in accordance with CGMP.

It went on to say, ‘Correct any violations as soon as possible. The USFDA may defer acceptance of new applications or supplements naming your company as a drug producer until any breaches are resolved, and we validate your compliance with CGMP. Failure to remedy any infractions may result in the FDA continuing to reject entry of items made at the factory, according to the statement.

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