FDA WARNING_LETTER - Laboratoires Clarins - September 21, 2018

The FDA inspected Laboratoires Clarins' drug manufacturing facility in Pontoise, France, from September 17 to 21, 2018, identifying significant violations of current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211). Consequently, the firm's drug products are deemed adulterated under section 501(a)(2)(B) of the FD&C Act. Key deficiencies included a failure to thoroughly investigate out-of-specification (OOS) test results for critical product attributes, lacking root cause determination and effective corrective and preventive actions (21 CFR 211.192). The firm also failed to establish adequate written procedures for production and process control, specifically lacking process validation and equipment qualification for its drug products (21 CFR 211.100(a)). Furthermore, Laboratoires Clarins did not demonstrate that its cleaning and disinfection practices for equipment were adequate to remove contaminants, relying only on visual examination (21 CFR 211.67(a)). The FDA found the firm's responses to these observations inadequate and, due to the nature of the violations and repeat observations, strongly recommended engaging a qualified CGMP consultant. The firm must respond within 15 working days, detailing corrective actions and recurrence prevention, or provide a schedule for completion. Failure to correct these violations may lead to FDA withholding approval of new applications and refusing admission of products into the United States.