News

Jan 28, 2026 -

Handlingmicrobiologicaldeviations:TheU.S.FDAhasclearideas

Oops, it caught an Australian manufacturer of OTC products. As the leading European provider of GMP training in Europe, Concept Heidelberg, has just reported in its newsletter, the FDA has issued a corresponding so-called “warning letter” due to significant GMP violations.

The regulatory authority criticized, among other things:

Inadequate processing of the case (Root cause analysis, risk assessment, CAPA procedures, etc.)
Missing validation documents for microbiological rapid methods (the extensive chapter <1223> Validation of Alternative Microbiological Methods of the United States Pharmacopeia (USP) is available here)
Yes/no procedures (=qualitative examination methods) do not replace enumeration methods (=quantitative examination methods)

Note: we also use alternative methods at BAV Institute, e.g., for the rapid detection of Listeria. However, a comprehensive validation program was always conducted before their promotion and use. In some cases, the extensive protocols of the French standardization organization (AFNOR) are also used.

Numerous cosmetic and pharmaceutical companies rely on our range of services, from monitoring to microbiological quality control according to relevant pharmacopeias or DIN-EN-ISO standards, from identification using MALDI-TOF and sequencing to assistance in the event of an emergency.

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