20-22 June 2023
The U.S. Food and Drug Administration (FDA) has published a so-called untitled letter dated 05 December 2022 to Valisure, LLC, a US drug contract testing laboratory.
The FDA states that the company violated the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Drug Supply Chain Security Act (DSCSA) while owning ValisureRx. ValisureRx was sold in the meantime. Until the sale, it was a subsidiary of Valisure, LLC.
ValisureRx was a licensed pharmacy and wholesale drug distributor. During an inspection, the FDA investigators reviewed several records. Among other things, the following GDP violations were found:
The FDA concludes that the company had no system in place to ensure compliance with the DSCSA.
The company also provides contract testing services for wholesale distributors and pharmacies. In this context, several current good manufacturing practice (CGMP) violations were documented by the FDA inspectors. This concerns among others the following areas:
To view the complete list of violations and the conclusion given by the FDA, please see the PDF document published on the FDA's website.