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11.03.2025 - Cosmetics

FDA warning letter due to inadequate testing of non-sterile drugs

The US Food and Drug Administration (FDA) conducted inspections last September at a manufacturer of non-sterile pharmaceuticals and identified significant deficiencies related to Good Manufacturing Practice (GMP). 

The following points, among others, were criticized in a warning letter:
- no validated systems for environmental monitoring in aseptic processing, posing a risk of microbial contamination
- lack of cleaning validation and quality control systems, making it impossible to verify consistent quality and purity of manufactured products
- inadequate documentation of manufacturing processes, affecting the traceability and composition of products

If you have questions about the microbiological testing of non-sterile pharmaceuticals or need advice regarding GMP, please feel free to contact us. 

Source: www.fda.gov