Virgin Scent Inc. dba Artnaturals

Warning LetterOpen

Mr. Yosef Nourollah Chief Executive Officer Virgin Scent Inc. dba Artnaturals 2390 Crenshaw Blvd, PMB #702 Torrance , CA 90501 United StatesFEI 3012303419Issued Sep 1, 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 3012303419.

Violations5

Issue DateSep 1, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: Virgin Scent Inc. dba Artnaturals
Location: Mr. Yosef Nourollah Chief Executive Officer Virgin Scent Inc. dba Artnaturals 2390 Crenshaw Blvd, PMB #702 Torrance , CA 90501 United States
FEI Number: 3012303419
Country: United States
Issue Date: September 01, 2022
Issuing Office: Division of Pharmaceutical Quality Operations IV
Product Type: Drugs
Status: Open

Summary

Virgin Scent Inc. dba Artnaturals faced enforcement action for manufacturing adulterated hand sanitizer and isopropyl alcohol products that contained unacceptable levels of impurities, violating Current Good Manufacturing Practice (CGMP) regulations under 21 CFR parts 210 and 211. An FDA inspection of the company's Gardena, California facility from February to March 2022 identified significant deficiencies in methods, facilities, and controls for manufacturing, processing, packing, and holding drug products. Additionally, multiple hand sanitizer and alcohol products were not properly listed with the FDA as required by law, compounding the compliance failures identified during the inspection.

Virgin Scent Inc. dba Artnaturals FDA Warning Letter, September 1, 2022