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24.06.2025 - Cosmetics

USHealthAuthorityFDArequestsrootcauseanalyses

The U.S. Food and Drug Administration (FDA) continues to conduct GMP inspections of pharmaceutical manufacturers in the EU, with consequences: A Dutch manufacturer recently received a so-called Warning Letter, as reported by GMP-Navigator from CONCEPT Heidelberg. The agency found serious deficiencies in handling microbiological limit exceedances as well as in root cause analysis and implementation of CAPAs (Corrective and Preventive Actions).

The FDA specifically criticized:

• inadequate root cause analysis for deviations,
• no systematic evaluation of potentially affected batches,
• a total of 7 microbiological exceedances — in two cases up to 10,000 CFU/ml — without a comprehensible response.
• The reference to the "current Good Manufacturing Practice" (cGMP) and the requirements from 21 CFR Parts 210/211 makes it clear: The demands on quality assurance and documentation remain high — especially in the international context.

The BAV Institute supports pharmaceutical companies in preparing for regulatory inspections, particularly with microbiological issues and in the area of GMP-compliant documentation. For questions about audits, microbiological quality control, and CAPA systems, our customer advisors are at your disposal.

Sources:

www.gmp-navigator.com