FDA WARNING_LETTER - Curia New York, Inc. - February 05, 2026

The U.S. Food and Drug Administration (FDA) issued a warning letter to Curia New York, Inc. following an inspection of its Rensselaer manufacturing facility from January 28 to February 5, 2026. The inspection identified serious deviations from Current Good Manufacturing Practice (CGMP) standards for active pharmaceutical ingredients (APIs). These violations led the FDA to classify the company’s products as adulterated under the Federal Food, Drug, and Cosmetic Act.

The core issues center on widespread data integrity failures. Investigators discovered that laboratory staff performed thousands of unexplained "trial" injections on chromatography equipment using administrative roles that bypassed standard oversight. Additionally, the facility’s Quality Unit failed to ensure proper record retention; original laboratory data, such as instrument printouts, were discovered in shred bins rather than being preserved as required. The FDA also noted that employees shared login credentials for computerized systems, making it impossible to accurately attribute testing activities to specific individuals.

To address these concerns, Curia New York must provide a comprehensive, independent assessment of its data-integrity practices across all facilities. This includes a retrospective review of all unexplained injections and discarded documents to determine their impact on product quality. The company is also required to develop a global corrective and preventive action (CAPA) plan, hire a dedicated data integrity compliance officer, and conduct a formal risk assessment for all drugs currently on the market. Failure to resolve these issues promptly may result in further regulatory action, such as the withholding of export certificates or legal injunctions.