Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistSeoul Cosmetics Co., Ltd. was cited for manufacturing drug products in violation of Current Good Manufacturing Practice (CGMP) regulations, resulting in adulterated and unapproved new drugs being introduced into interstate commerce. During a January-February 2023 inspection of their South Korean facility, investigators identified significant violations including failure of the quality control unit to ensure manufactured products met established specifications and CGMP requirements. The company's February 2023 response to the FDA's Form 483 was deemed inadequate due to insufficient detail and lack of sufficient corrective action evidence to bring operations into compliance with drug manufacturing standards.