FDA EIR - Valisure, LLC - July 06, 2021

A comprehensive FDA inspection of Valisure, LLC, located in New Haven, CT, was conducted from May 26 to July 6, 2021. This for-cause, high-priority inspection aimed to assess the firm's operations for compliance with Current Good Manufacturing Practices (CGMP) regarding contract testing, distribution decisions, drug storage, and wholesaler distribution under the Drug Supply Chain Security Act (DSCSA). The firm had expanded its services to include contract testing of pharmaceutical drug products.

At the conclusion of the inspection, an FDA Form 483 was issued, detailing six significant observations. Valisure failed to adequately verify or validate analytical methods used for testing elemental impurities, nitrosamines, methanol, benzene, acetaldehyde, acetal, and dosage. Its equipment qualification program was found inadequate, lacking full qualification for laboratory instruments. Control over electronic data was deficient due to shared administrative logins. Furthermore, the firm lacked a formalized written process for investigating out-of-specification laboratory events. Critically, Valisure had none of the verification systems required by the DSCSA and no procedures to notify trading partners or the FDA about illegitimate products. Two additional issues—undocumented employee training and the absence of a change management system—were discussed. Despite Valisure asserting its ISO accreditation rather than CGMP compliance, the inspection highlighted serious deviations from regulatory requirements under the FD&C Act, necessitating significant corrective actions to ensure drug quality and safety.