Drugs

Sterling Drug Supply Chain Violations

A 3/4-3/6 FDA inspection at the Sterling Distributors wholesale distribution facility in Coral Springs, FL, found significant violations of Drug Supply Chain Security Act (DSCSA) requirements. A 6/5 Warning Letter says the specific violations were:

engaging in wholesale distribution of prescription drugs without being appropriately licensed;
conducting unauthorized transactions with trading partners;
failing to respond to requests for information from state and federal officials;
failing to identify suspect product in the company’s possession or control; promptly conduct an investigation with trading partners to determine whether a suspect product is an illegitimate product; determine, in coordination with the manufacturer, whether product in the company’s possession or control is illegitimate; respond to notifications of illegitimate product from trading partners; and make notifications of illegitimate product to FDA and trading partners;
failing to collect and maintain transaction information and transaction statements; and
failing to have systems in place to enable compliance with the law’s verification requirements.

FDA acknowledges the corrective actions Sterling has committed to and taken, but says the firm’s response to a form FDA-483 is inadequate because there is insufficient information about how the company will ensure compliance with the law going forward. The letter also says the company response does not acknowledge that as early as 11/2024, it knew or should have known that it was distributing prescription drugs without a wholesale distributor or prescription drug license, and that by 12/2024 it was distributing suspect and illegitimate product and chose not to follow-up on those notifications.

“FDA is sending this compliance letter to Sterling because of the inherent risk to the supply chain when firms do not comply with the provisions of the DSCSA,” the letter says.

Sterling was told to respond with a list of specific actions it has taken to correct the violations and prevent their recurrence, with related documentation and a schedule for completing the corrections.

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