FDA WARNING_LETTER - RC Outsourcing, LLC - August 28, 2025

The FDA issued a warning letter to RC Outsourcing, LLC following an inspection from August 18 to August 28, 2025, at its Lowellville, Ohio facility. The inspection revealed that the company, which operates as a registered outsourcing facility, failed to comply with the Federal Food, Drug, and Cosmetic Act and Current Good Manufacturing Practice (CGMP) standards. Key violations included producing drugs under insanitary conditions, such as exposing sterile components to non-sterile surfaces and inadequate air quality. The agency also highlighted serious failures in quality control, including inadequate investigations into sterility failures and personnel health issues, as well as a lack of validated testing methods to ensure drug strength and purity. Furthermore, the company was cited for distributing unapproved new drugs and biologics, and for mislabeling products with incorrect dosage information. While RC Outsourcing initiated a voluntary recall of certain Bevacizumab syringes and suspended some production, the FDA found their initial corrective actions insufficient. The firm is required to hire a third-party consultant to perform a comprehensive assessment of its aseptic operations. Additionally, the company must provide a written response within 15 working days detailing the specific steps taken to correct these safety deficiencies and prevent their recurrence.