Mr. David Stern
President/Co-Owner
Verde Cosmetic Labs LLC
19845 Nordhoff Street
Northridge , CA 91324-3331
United StatesFEI 3014015976Issued Mar 30, 2022Division of Pharmaceutical Quality Operations IV
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 3014015976.
Violations5
Issue DateMar 30, 2022
Product TypeDrugs
StatusOpen
Letter Details
Firm
Verde Cosmetic Labs LLC
Location
Mr. David Stern
President/Co-Owner
Verde Cosmetic Labs LLC
19845 Nordhoff Street
Northridge , CA 91324-3331
United States
FEI Number
3014015976
Country
United States
Issue Date
March 30, 2022
Issuing Office
Division of Pharmaceutical Quality Operations IV
Product Type
Drugs
Status
Open
Summary
Verde Cosmetic Labs LLC manufactured OTC topical drug products (sunscreens, pain relief, and acne treatments) in violation of Current Good Manufacturing Practice regulations for finished pharmaceuticals. The FDA's September-October 2021 inspection identified critical failures in the company's quality control unit, including inadequate microbiological testing prior to product release, insufficient investigation of out-of-specification results, failure to document and assess manufacturing changes, lack of an adequate stability program, and failure to conduct annual product reviews. These control deficiencies rendered the company's drug products adulterated under the Federal Food, Drug, and Cosmetic Act.
Verde Cosmetic Labs LLC FDA Warning Letter, March 30, 2022