DSP Skin Care LLC

Warning LetterOpen

Mr. Ali A. Alkadi Owner and Director of Marketing DSP Skin Care LLC 1930 Wilshire Boulevard, Suite 507 Los Angeles , CA 90057-3649 United StatesFEI 3013374118Issued Jul 19, 2022Division of Pharmaceutical Quality Operations IV

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3013374118.

Violations9

Issue DateJul 19, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: DSP Skin Care LLC
Location: Mr. Ali A. Alkadi Owner and Director of Marketing DSP Skin Care LLC 1930 Wilshire Boulevard, Suite 507 Los Angeles , CA 90057-3649 United States
FEI Number: 3013374118
Country: United States
Issue Date: July 19, 2022
Issuing Office: Division of Pharmaceutical Quality Operations IV
Product Type: Drugs
Status: Open

Summary

DSP Skin Care LLC was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacturing of drug products, including the unapproved new drug Hongosan Anti-Fungal Set, which was also found to be misbranded. The company's manufacturing methods, facilities, and controls failed to meet federal standards, rendering their drug products adulterated, and the firm operated without proper FDA registration and drug product listing as required by law. An FDA inspection conducted September 7-9, 2021 at the Los Angeles facility identified these deficiencies, which violated multiple sections of the Federal Food, Drug, and Cosmetic Act and its implementing regulations.

DSP Skin Care LLC FDA Warning Letter, July 19, 2022