USFDA Issues Warning to Aspen Biopharma for Manufacturing Lapses

New Delhi, Apr 16 (PTI) The US health regulator has pulled up Aspen Biopharma Labs for various manufacturing lapses at its Telangana-based active pharmaceutical ingredients production facility.

In a warning letter to its CEO K Sateesh Reddy, the US Food and Drug Administration (USFDA) said the drug firm failed to design and construct buildings and facilities used in the manufacture of API in a manner to minimise potential contamination, facilitate appropriate cleaning, maintenance, and operations.

The USFDA inspected the Rangareddy-based facility from September 16 to 21, 2024.

This warning letter summarises significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (API), it stated.

"You produce higher-risk APIs in an inadequate facility, including one that lacks appropriate separation for high pharmacological activity or toxic materials," the USFDA stated.

"During the inspection, our investigator observed your facility was in a state of disrepair, with manufacturing areas open to the outdoor environment with inadequate protection of materials," it added.

The drug firm failed to appropriately validate processes and adequately qualify the equipment used to manufacture drugs, the USFDA stated.

It also pulled up the company for failure to design a documented, ongoing stability testing programme to monitor the stability characteristics of the API.

"We acknowledge that you deregistered your facility on January 6, 2025, however, it is unclear whether you intend to cease production of drugs for the US market. In response to this letter, clarify whether you intend to cease manufacturing drugs for the US market at this facility in the future," the USFDA stated.

If the company plans to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming drug manufacturing operations, it added.

A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations.

The letter also makes clear that the company must correct the problem and provides directions and a timeframe for its plans for correction.

FDA then checks to ensure that the company's corrections are adequate.