VET4U, LLC – FDA 483, Mar 11, 2026

Between March 9 and March 11, 2026, the FDA inspected VET4U, LLC, a drug distributor located in Clay, New York. The inspection identified significant deficiencies in the firm"s compliance with the Drug Supply Chain Security Act (DSCSA), which is part of the Federal Food, Drug, and Cosmetic Act. The primary issues involve inadequate internal systems for the verification and investigation of suspect pharmaceutical products. Specifically, the company’s quality protocols failed to establish procedures for identifying suspect items, collaborating with trading partners on investigations, or responding to official notifications of illegitimate products. Additionally, the firm lacked a system to maintain required records for the mandatory six-year retention period. Investigators noted a critical failure where VET4U, LLC did not investigate products in its possession after learning of a legal indictment involving its primary trading partners for dealing in diverted goods. Furthermore, the firm accepted and distributed medications without obtaining the necessary transaction statements and information required to verify the legal chain of custody. Although these observations are preliminary, the company is expected to implement corrective actions to bring its quality management and tracking systems into regulatory compliance and provide a formal response to the FDA detailing these improvements.