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The Center for Drug Evaluation and Research (CDER) cited nonprescription/OTC issues.
November 19, 2025
By: Melissa Meisel
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, faci...
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