FDA WARNING_LETTER - Sterling Distributors - March 06, 2025

On June 5, 2025, the FDA issued a Warning Letter to Sterling Distributors following an inspection from March 4-6, 2025, at their Coral Springs, FL facility. The inspection revealed significant violations of the Drug Supply Chain Security Act (DSCSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Key violations include: 1. **Unlicensed Wholesale Distribution (FD&C Act Section 503(e))**: Sterling distributed prescription drugs from Florida to customers nationwide, including Arkansas and Mississippi, without holding the required state wholesale drug distribution licenses. 2. **Transactions with Unauthorized Trading Partners (FD&C Act Section 582(c)(3))**: Sterling purchased prescription drugs from an unauthorized wholesale drug distributor, (b)(4), which had not submitted required annual reports to the FDA regarding state licensure. Sterling failed to verify their partner's authorization. 3. **Failure to Respond to Information Requests (FD&C Act Section 582(c)(1)(C))**: Sterling failed to respond to subpoenas and requests for records from the Arkansas and Mississippi Boards of Pharmacy (BoP) and the FDA regarding suspect or illegitimate products. 4. **Failure to Identify and Investigate Suspect/Illegitimate Product (FD&C Act Section 582(c)(4))**: Sterling failed to investigate a "mispackaged" product,