From turning away inspectors to falsifying data and leaving "bare footprints" in production containers, two of the latest warning letters posted by the FDA read like an instruction manual on what not to do when the regulator comes knocking at your manufacturing plant.
Jagsonpal Pharmaceuticals and Tyche Industries, both makers of APIs based in India, were slammed by the FDA in separate warning letters posted to the regulator's website this week. Both companies were placed on the FDA's import alert list as well, given the magnitude of their missteps.
In the case of Jagsonpal, based in the tech and financial hub Gurugram near New Delhi, an inspection conducted between last March and April found that the company had a third-party contract manufacturer produce active pharmaceutical ingredients, which it then claimed as its own on import records.
The company also was cited for refusing entry to FDA inspectors on March 15, 2024. The agency’s team was eventually granted permission to enter the facility on March 20, however, inspectors said they received limited access to documents requested during the visit.
The FDA further chided Jagsonpal for failing to properly register its products and those produced for it by a third party with the FDA. The agency put products from Jagsonpal on import alert on Jan. 17.
Meanwhile, Tyche Industries was issued its warning letter on Feb. 6 following an inspection of the company's Kakinada manufacturing plant last August. The company previously received and responded to an FDA Form 483 tied to the inspection, but the U.S. drug regulator apparently found its response lacking.
Tyche's warning letter focuses primarily on the quality control unit at its facility, which the FDA accused of failing to ensure the integrity of the company's manufacturing process records.
“During the inspection, a member of your management stated that two of your operators admitted to falsifying temperature data for a drying oven that was not turned on during the manufacture of a (redacted) batch," the agency said. That batch later failed to meet a residual solvents specification test.
Additionally, during the inspection, three managers admitted to taking part in preparing a “backdated calculation sheet” that was given to a FDA inspector, according to the letter.
The facility was also cited for contamination issues after a “rust-like” residue was found in one production container and “bare footprints” were found inside another, although both were labeled as clean and ready for use.
Tyche was placed on the FDA’s Import Alert list Jan. 2.