New Delhi, April 16 (PTI), U.S. health regulators have pulled up Aspen Biopharma Labs in their Telangana-based active pharmaceutical ingredients production facilities for various manufacturing mistakes.
In a warning letter to its CEO K Sateesh Reddy, the U.S. Food and Drug Administration (USFDA) said the drug company failed to design and build buildings and facilities for manufacturing APIs in a way to minimize potential pollution, thereby promoting proper cleaning, maintenance, maintenance and operation.
USFDA inspected the Rangareddy-based facility from September 16 to 21, 2024.
This warning letter summarizes significant deviations in active pharmaceutical ingredients (API) related to current Good Manufacturing Practice (CGMP).
“You generate high-risk APIs in inadequate facilities, including facilities that lack appropriately isolated highly pharmacological activities or toxic substances,” the USFDA said.
It added: “During the inspection, our investigators observed that your facility was in disrepair, that the manufacturing area was open to the outdoor environment and that the materials were insufficiently protected.”
USFDA said the drug company failed to properly verify the process and fully verify the equipment used to make drugs.
It also improves companies because they fail to design documented, ongoing stability testing programs to monitor API stability characteristics.
“However, you inspected your facility on January 6, 2025, but it is not clear whether you intend to stop manufacturing drugs for the U.S. market. In response to this letter, clarify whether you intend to stop manufacturing drugs for the U.S. market in the future,” the USFDA said. ”
It added that if the company plans to resume any manufacturing operations under the FD&C Act, please notify the office before resuming the drug manufacturing operations.
Warning letters are issued when U.S. health regulators find manufacturers seriously violate their regulations.
The letter also clearly shows that companies must correct the problem and provide instructions and timetables for their correction plans.
The FDA then checks to make sure the company’s corrections are sufficient.
