Supply Chain Violations at Safe Chain Solutions

A 4/11-5/11/22 FDA inspection at the Safe Chain Solutions wholesale drug distribution facility in Cambridge, MD, found violations of the Drug Supply Chain Security Act (DSCSA). A 6/8 Warning Letter says FDA observed that the company did not have adequate verification systems in place, failed to maintain records regarding suspect product investigations, and engaged in transactions with unauthorized trading partners. The letter says specific violations were:

• failing to have systems in place to enable compliance with DSCSA verification requirements;
• conducting transactions with unauthorized trading partners;
• failing to maintain records of suspect product investigations; and
• failing to respond to a notification of illegitimate product.

FDA says the firm’s response to a form FDA-483 was inadequate. Safe Chain was told to respond with a list of specific actions it has taken to address any violations and prevent their recurrence, with a schedule for completing the corrections.