FDA WARNING_LETTER - Safe Chain Solutions, LLC - May 11, 2022

The FDA issued Warning Letter #636044 to Safe Chain Solutions, LLC (Safe Chain) on June 8, 2023, following an inspection from April 11 to May 11, 2022, at their Cambridge, MD facility. The letter identifies significant violations of the Drug Supply Chain Security Act (DSCSA), specifically Section 582(c) of the FD&C Act, aimed at securing the pharmaceutical supply chain.

Key violations include: 1. **Failure to have adequate verification systems (Section 582(c)(4)(A) & (B))**: Safe Chain's "Standard Operating Procedure for Suspect & Illegitimate Product" lacked sufficient detail for identifying suspect product, conducting investigations, handling notifications, responding to FDA verification requests, making cleared product notifications, and maintaining records. Their SOP also incorrectly stated that disposition of illegitimate product depends on FDA guidance, and their notification timeline for illegitimate product (3 days) was inconsistent with the DSCSA's 24-hour requirement. 2. **Engaging in transactions with unauthorized trading partners (Section 582(c)(3))**: Safe Chain purchased drug products from wholesale distributors, such as Gentek and Boulevard 9229 LLC, that had not reported their state licensure to FDA as required by Section 503(e) of the FD&C Act. Boulevard 922