U.S. health regulator pulls up Jagsonpal Pharmaceuticals for manufacturing lapses at API plant

USFDA issues warning letter to Jagsonpal Pharmaceuticals for manufacturing lapses at Rajasthan plant, demands corrective action within 15 days.

The U.S. health regulator has pulled up Jagsonpal Pharmaceuticals for significant manufacturing lapses at its Rajasthan-based active pharmaceutical ingredients (APIs) plant.

In a warning letter issued to the company's Managing Director Manish Gupta, the U.S. Food and Drug Administration (USFDA) noted that the correspondence summarizes significant deviations from Current Good Manufacturing Practice for APIs.

The U.S. health regulator stated that it inspected the company's Bhiwadi- based plant in Rajasthan on March 20, March 27, and April 3, 2024. "This warning letter summarises significant deviations from Current Good Manufacturing Practice (CGMP) for APIs. Because the methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API is adulterated," the USFDA stated in the warning letter.

A warning letter issued by the USFDA usually identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use.

The letter also makes clear that the company must correct the problem and provides directions and a timeframe of its plans for correction. FDA then checks to ensure that the company's corrections are adequate. The USFDA noted that the company's quality systems were inadequate.

It pointed out failure of the company's quality unit to exercise its responsibility to ensure the API manufactured at the contract facility is in compliance with CGMP.

"FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labellers. FDA regards contractors as extensions of the manufacturer. You are responsible for the quality of your drugs regardless of agreements in place with your contract facility," it noted.