Sklar Personal Care Inc.

Warning LetterOpen

Mr. Ross Sklar Chief Executive Officer Sklar Personal Care Inc. 3137 East 26th Street Vernon , CA 90058 United States Ross@starcobrands.comFEI 3007953761Issued Dec 9, 2025Center for Drug Evaluation and Research (CDER)

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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 3007953761.

Violations4

Issue DateDec 9, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Sklar Personal Care Inc.
Location: Mr. Ross Sklar Chief Executive Officer Sklar Personal Care Inc. 3137 East 26th Street Vernon , CA 90058 United States Ross@starcobrands.com
FEI Number: 3007953761
Country: United States
Issue Date: December 09, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Sklar Personal Care Inc. was found to be manufacturing adulterated OTC drug products due to significant Current Good Manufacturing Practice (CGMP) violations at its North Carolina facility during a May-June 2025 inspection. The company failed to conduct required identity testing on incoming raw material components before using them in drug manufacturing, with particular concern raised regarding untested raw materials that could be contaminated with methanol—a substance linked to lethal poisoning incidents in other contexts. Without adequate incoming component testing, the firm lacked scientific evidence that raw materials met appropriate specifications before incorporation into finished drug products, directly violating 21 CFR 211.84(d)(1).

Sklar Personal Care Inc. FDA Warning Letter, December 9, 2025