FDA WARNING_LETTER - Mirfeel Korea Co., Ltd. - June 22, 2022

FDA issued a Warning Letter to Mirfeel Korea Co., Ltd., an OTC drug manufacturer, following the discovery of significant violations. FDA testing of their MOISTURIZING HAND SANITIZER Peppermint Scented product, distributed in the U.S., revealed unacceptable levels of benzene (5-6 ppm), a known carcinogen, indicating a failure in quality assurance per section 501(a)(2)(B) of the FD&C Act. The firm also failed to conform to Current Good Manufacturing Practice (CGMP) requirements, leading to adulterated drug products. Specific CGMP violations included failure to conduct appropriate finished product testing for identity and strength of active ingredients before release (21 CFR 211.165(a)), inadequate identity testing of raw materials and failure to validate supplier analyses (21 CFR 211.84(d)(1) and 211.84(d)(2)), and lack of an adequate stability testing program to determine storage conditions and expiration dates (21 CFR 211.166(a)). Additionally, the MOISTURIZING HAND SANITIZER product line was deemed misbranded under section 502(i) of the FD&C Act because its 1.01 oz containers resembled food pouches, posing a risk of accidental ingestion. The FDA strongly recommended engaging a qualified CGMP consultant and performing a comprehensive audit. All the firm's drug products were placed on Import Alerts 66-78 and 66-40, prohibiting their entry into the U.S. until compliance is demonstrated. A written response detailing corrective actions is required within 15 working days.