FDA 483 - Sterling Distributors - March 03, 2025

During an inspection conducted from March 3-6, 2025, the FDA issued a Form 483 to Sterling Distributors, LLC, located in Coral Springs, FL. The inspection revealed significant violations related to the distribution of prescription drug products. The company was found to be engaging in wholesale distribution of prescription drugs from August 2024 to February 2025 without holding the required state license, a breach of FD&C Act Section 503(e). Furthermore, Sterling Distributors, LLC demonstrated widespread non-compliance with the Drug Supply Chain Security Act (DSCSA), as outlined in FD&C Act Section 582(c). Key issues included purchasing and selling products with an unauthorized trading partner, even after being alerted to potential illegitimate products. The firm also failed to respond to multiple requests for information from federal and state regulators regarding suspected counterfeit or diverted products. They did not investigate notifications of illegitimate product from trading partners, nor did they notify other trading partners or the FDA about confirmed counterfeit products returned to them. The company lacked essential systems for verifying product authenticity, conducting investigations, and managing notifications as mandated by the DSCSA. Sterling Distributors, LLC must implement comprehensive corrective actions to ensure proper licensing and full adherence to all federal drug supply chain security regulations to prevent the distribution of illegitimate products.