US FDA flags quality lapses at Sun Pharma's Gujarat plant: Report

Representative image.

The US health regulator has flagged production-related quality control and procedural lapses, as well as deficient equipment and laboratory standards, at the Gujarat facility of Sun Pharma, India’s largest drugmaker.

 The US Food and Drug Administration conducted a good manufacturing inspection of Sun Pharmaceutical Industries Ltd's Halol facility from April 26 to May 9, according to the company’s exchange filing.

 “We hereby inform you that the US FDA conducted a Good Manufacturing Practices (GMP) inspection of Sun Pharmaceutical Industries Limited's Halol facility (Gujarat, India) from April 26 to May 9, 2022,” the company said in the filing, a copy of which is with Moneycontrol.

At the conclusion of the inspection, the US FDA issued a Form-483, with 10 observations, the company said, adding that it was preparing a response to the observations, which will be submitted to the US FDA within two weeks of business days.

“The company is committed to addressing these observations promptly. The company remains committed to working closely with the US FDA and continues to enhance its GMP compliance on an ongoing basis,” it said.

A report in BQ Prime listed the ten observations by the US FDA.

“Procedures designed to prevent microbial contamination of drug products did not include adequate validation of aseptic processes. The procedures performed for injectable suspension are a high-risk manually intensive dispensing and compounding process. Deficiencies were identified in the media filling process (that could lead to rejection or recall of batches) and the review videos for the media filling,” one of the observations reported by BQ Prime said.

“Quality unit failed to fulfil responsibilities as per standard operating procedures. It also failed to take timely market action in accordance with drug recall procedure (failure to recall non-confirming batches and recall initiated close to expiry),” another observation said.

Moneycontrol could not independently verify the FDA’s observations. A response to related queries is awaited from the US FDA.