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Talk to a SpecialistTalk to a SpecialistHandock Cosmetics Co., Ltd. was cited for multiple serious violations at its drug manufacturing facility in South Korea, including failure to conduct component identity testing and inadequate corrective actions in response to FDA inspection findings. The company's Hand Sanitizer Perfect Care Gel was introduced into interstate commerce as an unapproved new drug, while both that product and Dr. Clean Perfect Gel were misbranded in violation of FDA regulations. The facility's manufacturing methods, facilities, and controls failed to meet Current Good Manufacturing Practice (CGMP) requirements, rendering the drug products adulterated. The company's April 2023 response to the FDA's Form 483 was deemed insufficient for demonstrating compliance with CGMP standards.