The FDA has issued a warning to wholesale drug distributor Safe Chain Solutions over four major violations — including ones related to counterfeit and unapproved drugs — which the agency found after an inspection it conducted between April and May.
The June 8 warning letter outlines what the FDA stated were "significant violations" of the Drug Supply Chain Security Act including:
- Failure to have clear directions and systems in place to identify and investigate suspected illegitimate products and handle accordingly.
- Failure to verify that all trading partners of the company had also reported licensure information to the FDA and then proceeding to conduct transactions with these partners who were not authorized.
- Failure to maintain records and documentation of suspected illegitimate products and subsequent investigations into them.
- Failure to properly respond after receiving a notification about an illegitimate product.
Following the FDA's investigation, Safe Chain Solutions hired a third-party consultant to help it begin to address some of the inadequacies found in the FDA's inspection, however, the FDA noted it was still not up to par.
"FDA understands that your firm hired a third-party consulting firm after FDA's inspection to assist in reviewing and enhancing all the company's [standard operating procedures]," the agency wrote. "However, your firms' new SOP, 'Handling and Reporting Suspect and/or Illegitimate Products' (effective 5/5/22) contains information not consistent with the DSCSA."
In addition, the FDA notes that in its response to initial findings, Safe Chain Solutions also claimed that it had "never knowingly purchased illegitimate products from any" of its vendors. In this new warning letter the FDA refuted that claim and stated that the response is "inadequate" and failed to provide any "documentation demonstrating the rationale … that the issue was at the retailer/pharmacy level."
Becker's reached out to Safe Chain Solutions to comment on this matter and a spokesperson shared the following reply: "Safe Chain’s safety protocols and SOPs comply with all federal and state regulations. This will be described fully in our response to the FDA letter, which will be submitted tomorrow [June 29]."