Imperial Palace Commodity -Dongguan- Co., Ltd. – FDA Warning Letter, Jan 27, 2025

The FDA issued a Warning Letter to Imperial Palace Commodity (Dongguan) Co., Ltd., an OTC drug product manufacturer, following a review of records submitted under section 704(a)(4) of the FD&C Act. Dated January 27, 2025, the letter identifies significant Current Good Manufacturing Practice (CGMP) violations, rendering the firm's drug products adulterated under 21 U.S.C. 351(a)(2)(B). Key deficiencies include the firm's failure to adequately test incoming components for identity, purity, strength, and quality, specifically for glycerin (risk of DEG/EG) and ethanol (risk of methanol), and to validate supplier COAs (21 CFR 211.84(d)(1) and (d)(2)). The firm also failed to establish adequate written procedures for production and process control, lacking proper process validation and water system validation (21 CFR 211.100(a)). Additionally, laboratory controls were inadequate, particularly for microbiological stability testing (21 CFR 211.160(b)), and the Quality Control Unit failed to exercise its responsibilities effectively (21 CFR 211.22(a)). The FDA recommends engaging a qualified CGMP consultant for a comprehensive six-system audit. Due to these violations, the firm's products were placed on Import Alert 66-40, and failure to correct deficiencies may lead to continued import refusal and withholding of new drug application approvals. A written response detailing corrective actions is required within 15 working days.