The United States Food and Drug Administration (FDA) inspected DermaRite Industries, LLC’s manufacturing facility in North Bergen, NJ and issued a violation as seen from March 26 to April 8, 2025.

This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, according to the letter.

The Center for Drug Evaluation and Research (CDER) cited nonprescription/OTC issues.

The FDA noted: “Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).”

In addition, there were a variety of DermaSeptin products that are unapproved new drugs introduced or delivered for introduction into interstate commerce.

Read the full letter here.