DermaRite Industries, LLC

Warning LetterOpen

Mr. Fabian McCarthy CEO DermaRite Industries, LLC 7777 West Side Avenue North Bergen , NJ 07047 United StatesFEI 1000526900Issued Oct 27, 2025Center for Drug Evaluation and Research (CDER)

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Violations7

Issue DateOct 27, 2025

Product TypeOther

StatusOpen

Letter Details

Firm: DermaRite Industries, LLC
Location: Mr. Fabian McCarthy CEO DermaRite Industries, LLC 7777 West Side Avenue North Bergen , NJ 07047 United States
FEI Number: 1000526900
Country: United States
Issue Date: October 27, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Other
Status: Open

Summary

DermaRite Industries, LLC received a warning letter for significant Current Good Manufacturing Practice (CGMP) violations at its drug manufacturing facility in New Jersey, making its drug products adulterated and unfit for commerce. Five specific OTC products—DermaSeptin Ointment Skin Protectant with Cooling Menthol, Lantiseptic Moisture Shield Original Skin Protectant, DermaMed Ointment Skin Protectant, DermaFungal Antifungal Cream with 2% Miconazole Nitrate, and PeriGiene Health Care Antiseptic—were identified as unapproved new drugs introduced into interstate commerce in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act. Additionally, several products were cited as misbranded under sections 502(f)(1) and 502(ee) of the FD&C Act, indicating deficiencies in manufacturing methods, facilities, and controls.

DermaRite Industries, LLC FDA Warning Letter, October 27, 2025