FDA issues warning letter to Darmerica, LLC for significant CGMP and labelling violations

21st January 2026

Summary: The FDA inspected Darmerica’s API manufacturing facility in Davie, Florida between 3–19 March 2025 and found serious deviations from Current Good Manufacturing Practice (CGMP) regulations. As a result, active pharmaceutical ingredients (APIs) produced at the site were considered adulterated under the Federal Food, Drug, and Cosmetic Act because the company’s manufacturing methods, facilities and controls failed to meet required quality standards. Additionally, Darmerica distributed drugs with misleading or inaccurate labelling and inadequate directions for use, meaning those products were also misbranded. The warning letter cites violations of multiple provisions of the FD&C Act related to product adulteration, misbranding and failure to properly list drugs in the FDA’s registration system. The FDA expects Darmerica to take prompt corrective and preventive actions to address these systemic quality issues.

Link: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025

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