FDA Tracker

FDA Cites 503B Facility RC Outsourcing for Production Deficiencies That "Put Patients at Risk"

Warning Letter

FDA Cites 503B Facility RC Outsourcing for Production Deficiencies That "Put Patients at Risk"

On March 20, 2026, FDA issued a warning letter to RC Outsourcing, LLC (Lowellville, OH), a registered 503B outsourcing facility, citing "Adulterated Drug Products." After an August 2025 inspection, FDA noted "serious deficiencies in your practices for producing drug products, which put patients at risk." The letter acknowledges a September 2025 voluntary recall of four lots of Bevacizumab 1.75 mg/0.07 mL syringes due to a lack of sterility assurance.

What this meansNo GLP-1 products are named here, but 503B facilities anchor the compounding supply chain — FDA’s inspection findings are the public record patients and prescribers can use to vet them.

Source: FDA original ↗

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