FDA WARNING_LETTER - Darmerica, LLC - March 19, 2025

The FDA issued a Warning Letter to Darmerica, LLC following an inspection of its drug manufacturing facility in Davie, FL, from March 3 to 19, 2025. The letter identified significant violations of Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs), rendering the company"s APIs adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Additionally, Darmerica distributed misbranded drugs due to false or misleading labeling, inadequate directions for use, and failure to properly list drugs in accordance with the FD&C Act and 21 CFR Part 207.

Key issues included the company"s quality unit failing to ensure CGMP compliance, particularly regarding material receipt, repackaging, and relabeling of APIs. Specific deviations highlighted an inadequate system for evaluating suppliers, exemplified by qualifying a supplier that provided inconsistent regulatory inspection history and lacked stability data capabilities. Furthermore, Darmerica failed to adequately investigate quality-related complaints, such as not contacting all affected customers after receiving reports of black chunks in an API lot. The FDA deemed the company"s initial response to the inspection findings inadequate, necessitating comprehensive corrective actions to address the identified systemic deficiencies.