USFDA pulls up Jagsonpal Pharmaceuticals for manufacturing lapses at API plant

New Delhi: The US 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 US Food and Drug Administration (USFDA) noted that the correspondence summarizes significant deviations from Current Good Manufacturing Practice for APIs.

The US 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.

The USFDA alleged that its inspectors were refused entry into the facility on March 15, 2024. On March 20, 2024, the FDA was permitted to enter the facility at the registered address to conduct an inspection; however, access to requested documents was limited during the inspection, it added.

"When an owner, operator, or agent delays, denies, limits, or refuses an inspection, the drugs may be deemed adulterated," the USFDA stated.

Based upon the nature of the deviations identified, the company should engage a consultant qualified to evaluate operations and to assist in meeting CGMP requirements, it said.

"FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any deviations," the USFDA said.

It further stated: "The warning letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any deviations and to prevent their recurrence."