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Talk to a SpecialistTalk to a SpecialistMirfeel Korea Co., Ltd., a South Korean manufacturer of over-the-counter hand sanitizer products distributed in the U.S., was cited for manufacturing adulterated drugs due to benzene contamination at unacceptable levels, indicating inadequate quality assurance and failure to comply with Current Good Manufacturing Practice (CGMP) requirements. FDA laboratory testing of the company's Moisturizing Hand Sanitizer (Peppermint Scented) revealed the contamination, and subsequent review of the company's submitted records confirmed that their manufacturing methods, facilities, and controls did not conform to CGMP standards under 21 CFR parts 210 and 211. Additionally, the product packaging in 1.01 ounce containers was found to resemble food pouches in a manner that constituted misbranding under FDA regulations.