United Therapeutics Corporation – FDA 483, Feb 28, 2025

During an FDA inspection conducted from February 19 to February 28, 2025, United Therapeutics Corporation, a manufacturer located in Durham, NC, received a Form FDA 483 citing significant observations regarding its compliance with the Drug Supply Chain Security Act (DSCSA). The primary issue identified was the company's failure to establish adequate systems for verifying the legitimacy of drug products within the supply chain. Specifically, the FDA investigator observed a lack of written procedures to govern critical DSCSA requirements. These deficiencies included the absence of protocols for responding to verification requests from regulatory bodies or trading partners, managing notifications related to illegitimate products, and implementing procedures for identifying, quarantining, investigating, and ultimately disposing of suspect or illegitimate items. Furthermore, the company lacked established procedures for retaining samples of illegitimate products, conducting joint investigations with trading partners, terminating notifications, and maintaining proper records for product identifiers and investigation outcomes. To address these observations, United Therapeutics Corporation is required to develop and implement comprehensive written procedures for all specified DSCSA verification processes. This action is crucial to ensure the integrity and security of the drug supply chain and to prevent counterfeit or harmful products from reaching patients, aligning with federal regulations designed to enhance product traceability and safety.