FDA WARNING_LETTER - Naturich Cosmetique Labs - May 02, 2025

The Food and Drug Administration (FDA) issued a Warning Letter to Naturich Cosmetique Labs following an inspection from April 28 to May 2, 2025. The letter cited significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering the company"s over-the-counter drug products adulterated. Key issues included a failure to establish adequate written procedures for production and process control. Specifically, the firm"s water system, used in manufacturing topical drugs, was not adequately validated, maintained, sanitized, or monitored for quality, with a lack of microbial testing and appropriate design. Additionally, Naturich Cosmetique Labs failed to validate its manufacturing processes, leading to inadequate control over critical production steps and products exhibiting intra-batch potency variations, such as sub-potent and super-potent lotions. The company also failed to thoroughly investigate multiple out-of-limit microbiological results. The FDA deemed the company"s initial response inadequate due to insufficient documentation and evidence of corrective actions. Required actions include a comprehensive, independent assessment and remediation plan for the water system, a detailed validation program for all manufacturing processes, timelines for process performance qualification, a risk assessment for affected drug products, and improved investigation procedures for discrepancies.