The U.S. FDA has issued a warning letter to CDMO Brassica Pharma for "significant" CGMP violations at its manufacturing facility in Tarapur, India.
In a warning letter dated July 11, published on the FDA site yesterday, the agency outlined four observations from a January inspection. The running list of violations included failure to test batches for sterility as well as failed sterility tests, including one for a U.S. product. The FDA noted that Brassica staff told inspectors that it was "routine practice to fabricate records and results for samples that were not taken."
In addition, the letter documented a failure to perform sterility test method validation for all drug product formulations intended for U.S. distribution and that staff added "multiple steps or materials used that were not included as part of the initial validation."
Inspectors observed inadequate cleaning of aseptic processing equipment as well as poor practices and behaviors in ISO 5 and ISO 7 areas during the manufacturing of sterile drug product. The agency noted that "gowning worn by operators during aseptic processing activities was observed to be stained and torn."
The CDMO was already under fire from the agency, who placed the company on import alert in late January. A month later, Brassica agreed to suspend manufacturing and distribution of all drugs for the U.S. market and agreed to voluntarilly recall multiple eye ointment products in distribution in the U.S. due to the lack of sterility assurance at its facility.
Now, among the numerous requirements noted in the warning letter, the FDA wants Brassica to engage a qualified 21 CFR 211.34 consultant qualified if the CDMO intends to resume manufacturing drugs for the U.S. market.
