FDA WARNING_LETTER - Dermarite Industries, LLC. - April 08, 2025

The FDA issued a Warning Letter to DermaRite Industries, LLC following an inspection of their North Bergen facility from March 26 to April 8, 2025. The letter highlights significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR parts 210 and 211), rendering their drug products adulterated. The company also introduced several unapproved new drugs into interstate commerce and misbranded others, violating sections of the Federal Food, Drug, and Cosmetic Act. A primary CGMP violation involved the firm"s failure to thoroughly investigate unexplained discrepancies and out-of-specification (OOS) results. For instance, DermaRite released drug batches after obtaining passing results on retests, disregarding initial failing microbial count or active ingredient assay results, a practice known as "testing into compliance." Investigations into these failures were deemed inadequate, lacking root cause identification, effective corrective actions, and impact assessments on other products. The FDA noted voluntary recalls initiated by DermaRite for certain products due to microbial contamination. The agency requires the company to conduct a retrospective, independent review of all invalidated OOS/OOL results for products currently on the U.S. market. This review must determine if issues stemmed from laboratory error or manufacturing, and subsequently implement a comprehensive remediation plan for their OOS/OOL investigation systems, including enhanced Quality Unit oversight and thorough investigations into potential manufacturing causes when laboratory errors are not conclusively identified.