FDA WARNING_LETTER - Casmara Cosmetics, S.A. - May 31, 2017

The FDA inspected Casmara Cosmetics, S.A.'s drug manufacturing facility in Paterna, Spain, from May 29-31, 2017, 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. The inspection revealed four primary deficiencies: 1) failure to conduct appropriate laboratory testing for identity and strength of active ingredients in drug products prior to release (21 CFR 211.165(a)); 2) failure to test incoming components, including active pharmaceutical ingredients, for identity and other quality attributes, relying instead on unqualified supplier certificates of analysis (21 CFR 211.84(d)(1) and (2)); 3) an inadequate stability testing program that lacked active ingredient testing, preventing the determination of appropriate storage conditions and expiration dates (21 CFR 211.166(a)); and 4) failure to establish written procedures for production and process control, including unvalidated manufacturing processes and insufficient batch records (21 CFR 211.100(a)). The firm's initial response was deemed insufficient. FDA requires a detailed written response within 15 working days outlining comprehensive corrective actions, including specific test methods, timelines for testing all in-date products, supplier validation procedures, risk assessments for products containing (b)(4) and those lacking stability data, and process validation plans. The FDA strongly recommended engaging a CGMP consultant. As a result of these violations, the firm was placed on Import Alert 66-40, and FDA may withhold approval of new applications or refuse admission of products into the U.S. The letter also noted labeling concerns for OTC drug products.