Centrient API Plant Receives Warning Letter
Centrient Pharmaceuticals’ active pharmaceutical ingredient (API) facility in Punjab, India, received a warning letter from the FDA for multiple deficiencies including lax records, test validations and inadequate contaminant controls.
The FDA sent the warning after getting an unsatisfactory response by the company to a Form 483 inspection report issued July 1.
The agency investigators observed that the company’s quality unit lacked adequate controls over paper and electronic records. The agency also observed that the facility’s environmental controls were inadequate to prevent cross-contamination of non-beta-lactam and beta-lactam drugs such as penicillin, raising the risk of allergic reactions in patients.
The facility used a test method to detect beta lactams in buildings where non-beta-lactam drugs are manufactured that “was not appropriately validated and was not followed,” the agency said.
December 16, 2022
