FDA WARNING_LETTER - Seoul Cosmetics Co., Ltd. - February 03, 2023

The FDA inspected Seoul Cosmetics Co., Ltd. in South Korea from January 30 to February 3, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). The firm's quality control unit failed to ensure CGMP compliance and meet specifications (21 CFR 211.22), and adequate written procedures for production and process control, including process validation and equipment qualification, were not established (21 CFR 211.100(a)). Furthermore, several products, including (b)(4), and (b)(4), were identified as unapproved new drugs, violating 21 U.S.C. 355(a) and 331(d). Specifically, (b)(4) and (b)(4) are unapproved as they are not generally recognized as safe and effective (GRASE) under 21 CFR part 330. Additionally, (b)(4) and (b)(4) are unapproved new drugs because they do not conform to the conditions of use specified in the (b)(4) and contain unlisted active ingredients. The products (b)(4), and (b)(4) are also misbranded under 21 U.S.C. 352(ee) for failing to comply with nonprescription drug requirements under 21 U.S.C. 355h. The firm's response to the FDA 483 was deemed inadequate, and their quality systems were found deficient. FDA recommended engaging a qualified CGMP consultant to assist with compliance and audit operations. The firm was placed on Import Alert 66-40, and failure to correct violations may lead to continued refusal of product admission into the U.S. and withholding of new drug application approvals. A written response detailing corrective actions is required within 15 working days.