FDA Flags Critical GMP Failures at Naturich Cosmetique Labs

During a spring 2025 inspection, the FDA found serious GMP violations at Naturich Cosmetique Labs, a manufacturer of topical OTC products. The agency rejected the company’s response as inadequate and lacking corrective actions.

A major concern was the unvalidated water system used to produce skin-contact products. The system was not sanitised or microbiologically monitored, leaving no proof that the water met required quality standards. The firm also failed to assess risks to batches already on the market.

The FDA noted repeated microbiological out-of-limit findings, including Enterobacter cloacae, Burkholderia cepacia and Pseudomonas species, without effective root-cause investigation. The company continued to rely on a heating step to justify product release.

The agency also cited missing process validation, inconsistent mixing parameters and the release of under- and over-dosed lotions without proper evaluation.

The FDA is demanding full water-system remediation, a risk review of distributed batches and a complete process-validation programme.

01-12-2025