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Sterling Distributors, a wholesale drug distributor in Florida, violated the Drug Supply Chain Security Act (DSCSA) and Federal Food, Drug, and Cosmetic Act by engaging in wholesale distribution of prescription drugs without proper state and federal licensing as required under Section 503(e). During a March 2025 inspection, FDA investigators documented that the firm failed to comply with various DSCSA requirements intended to ensure product tracing, verification, and supply chain security to protect patients from counterfeit, stolen, or contaminated medications. The company received a Form FDA 483 on March 6, 2025, and submitted a response on March 26, 2025, but the violations were significant enough to warrant this formal warning letter from the Center for Drug Evaluation and Research.