FDA WARNING_LETTER - Nobilus Ent Oddzial Kutno - September 15, 2011

The FDA issued a Warning Letter to Nobilus Ent, an API manufacturer in Kutno, Poland, following a September 12-15, 2011, inspection. The inspection revealed significant deviations from CGMP for API manufacturing, rendering their APIs adulterated under 21 U.S.C. § 351(a)(2)(B).

The primary violation was the failure to use dedicated production areas, including facilities, air handling equipment, and process equipment, for penicillin operations, a highly sensitizing material. Specific deficiencies included: - Insufficient separation practices for penicillin manufacturing, leading to potential cross-contamination of other APIs. - Non-dedicated reaction, weighing, and storage areas for penicillin. - Inadequate separation of air handling systems for penicillin areas from other facility areas. - Lack of routine facility monitoring for penicillin cross-contamination (e.g., surface monitoring in non-penicillin areas). - Failure to routinely test all non-penicillin products for penicillin presence.

The FDA requires Nobilus Ent to implement a comprehensive containment plan, including full segregation of penicillin operations, dedicated equipment, separate air handling systems, and a robust testing plan for environmental surfaces and all non-penicillin products. If penicillin operations are discontinued, a decontamination, renovation, and requalification plan is required.

Until corrections are confirmed, FDA may withhold new application approvals and maintain the firm under Import Alert, refusing admission of all articles