GDP in the US: FDA warns Company for Violation of Drug Supply Chain Security Act

Recommendation

4/5 October 2023

The GDP Compliance Manager - Live Online Training

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:

• Failure to investigate suspect product;
• Failure to make determinations of illegitimate product in coordination with the manufacturer;
• Failure to notify FDA and required trading partner of illegitimate product.

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:

• Not suitable analytical methods were used;
• The verification of United States Pharmacopeia (USP) methods was inadequate;
• There was a lack of written procedures for out of specification (OOS) results;
• Analytical instruments have not been adequately qualified;
• No appropriate controls over electronic records were in place.

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.