FDA criticizes serious GMP violations in US pharmaceutical operation

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Nov 25, 2025 - Cosmetics

FDA criticizes serious GMP violations in US pharmaceutical operation

As the European provider of GMP training, Concept Heidelberg, reports in its current newsletter, the U.S. Food and Drug Administration (FDA) identified serious violations of Good Manufacturing Practice (GMP) during an inspection at a topical drug company in the first quarter of 2025. The company's response to the findings did not meet the agency's requirements.

The water system was particularly criticized: It had not been validated, and regular sanitation and microbiological monitoring were not performed. As a result, it was not ensured that water in the required pharmaceutical quality was available. The FDA now requires, among other things, regular microbiological tests at several sampling points and a comprehensive investigation of out-of-limit (OOL) results.

During the investigations, "objectionable microorganisms" were found at several sampling points, including Enterobacter cloacae, Burkholderia cepacia, and various Pseudomonas species. The agency emphasized that a subsequent heating step was not sufficient to meet CAPA (Corrective Action Preventive Action) requirements.

Microbiological water testing, especially for cosmetic and pharmaceutical companies, is one of the core competencies of the BAV Institute. For further questions, the institute's customer consultants are available.

Sources:

• www.gmp-navigator.com
• www.bav-institut.de
• www.gmp-navigator.com