Morton Grove Pharmaceuticals, a subsidiary of Wockhardt, received a warning letter from the FDA listing GMP compliance issues at its Illinois facility, including insufficient investigations into product instability.
The firm did not thoroughly investigate two batches of triamcinolone acetonide lotion USP 0.1% that failed stability testing, the letter said. The company initially traced the problem to an excipient used in the production process, but failed to determine the root cause.
In the February warning letter, the agency said Morton Grove concluded, without performing a science-based health hazard evaluation, that the impurities do not pose health risks. Inspectors separately cited the firm’s quality control unit for failures to test in-process materials, violating the terms of ANDA filings that described testing procedures.