With its active pharmaceutical ingredient (API) facility “in a state of disrepair,” manufacturer Aspen Biopharma Labs’ operations have ground to a halt in the U.S., according to a recent FDA reprimand.
Aspen Biopharma has been hit with an FDA warning letter outlining multiple issues at the company’s production facility in the Indian city of Hyderabad, including poor building design that could lead to drug contamination.
The rebuke comes in the wake of a Sept. 16-21 inspection of the Aspen plant and highlights four major production problems.
First and foremost, FDA inspectors found the company's facility failed to minimize the risk of contamination when producing "higher-risk APIs," the agency said in a letter posted to its website Tuesday.
During the September inspection, the agency found that Aspen's plant was “in a state of disrepair." Specifically, some manufacturing areas were open to the outdoors and materials were not adequately protected, the regulator said in its write-up. The inspectors also witnessed drugs being manufactured in a common area.
Aspen Biopharma told the FDA that it was in the process of renovating its facility, though the inspectors found that explanation subpar.
Additionally, the FDA said Aspen Biopharma didn’t complete process validation for commercial-size lots of API and lacked cleaning validation studies to demonstrate that its cleaning procedures were adequate.
The inspectors said that they observed manufacturing equipment labeled “Cleaned” that contained liquid with an undisclosed floating substance or residue on product-contact surfaces.
Aspen, which also was cited for poor records keeping and quality control problems, was placed on the FDA’s Import Alert list Jan. 15, preventing the company from selling drugs in the U.S.
The day after the manufacturer was placed on the list, Aspen Biopharma agreed to a voluntary recall of all drugs that it produced that were being distributed in the U.S. The voluntary recall was initiated Feb. 7, according to the FDA's letter.
Elsewhere on the subcontinent, fellow Indian API makers Jagsonpal Pharmaceuticals and Tyche Industries both recently received warning letters from the FDA that were made public last month.
Jagsonpal was cited for having a third-party contract manufacturer produce active pharmaceutical ingredients that it then claimed as its own on import records, while Tyche was scolded primarily over quality control shortfalls.