FDA WARNING_LETTER - DSP Skin Care LLC - September 09, 2021

The FDA inspected DSP Skin Care LLC from September 7-9, 2021, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering drug products adulterated under 21 U.S.C. 351(a)(2)(B). The firm failed to perform adequate laboratory testing for product release (21 CFR 211.165(a)) and lacked an adequate stability testing program (21 CFR 211.166(a)) for products like Hongosan Premium Plus Spray and Hongosan Anti-Fungal Set. The Quality Control Unit failed to ensure CGMP compliance and lacked essential written procedures and batch records (21 CFR 211.22).

Beyond CGMP, the Hongosan Anti-Fungal Set is an unapproved new drug (21 U.S.C. 355(a), 331(d)) as it does not conform to OTC Monograph M005, particularly regarding combination use and multiple active ingredients; its individual components are also unapproved. The product is also misbranded (21 U.S.C. 352(a), (c), (ee)) due to incomplete Drug Facts labeling (21 CFR 201.66(c)(2), (c)(8)) and non-compliance with section 505G.

Furthermore, DSP Skin Care LLC is not duly registered with FDA (21 U.S.C. 360, 21 CFR Part 207), with its registration expired since December 2017. Several products, including the Hongosan Anti-Fungal Set, Cream, and Premium Plus Spray, are not properly listed with FDA (21 U.S.C. 360(j), 21 CFR 207.41, 207.57). These issues, including repeat observations from a 2018 inspection, indicate inadequate quality systems and executive management oversight, prompting a recommendation for a CGMP consultant. The firm must respond within 15 working days with corrective actions to avoid further regulatory action, including seizure, injunction, and withholding of export certificates or application approvals.