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

Source: https://www.keypedia.com/records/warning_letter/nobilus-ent-oddzial-kutno/a2498568-9426-4080-adb3-22666ba3d11d

> FDA WARNING_LETTER for Nobilus Ent Oddzial Kutno on September 15, 2011. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Nobilus Ent Oddzial Kutno
- Inspection Date: 2011-09-15
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Officers

- [Steven J. Lynn](https://www.keypedia.com/people/steven-j-lynn/23c7bb25-33be-48e2-81fd-ab34c6096eac)

Company: https://www.keypedia.com/companies/nobilus-ent-oddzial-kutno/f3113759-ba51-4720-b2b9-df3f6473888c

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c