FDA 483 - RC Outsourcing, LLC - September 27, 2024

From September 17-27, 2024, the FDA inspected RC Outsourcing, LLC, an outsourcing facility in Lowellville, OH, owned by Raymond R. Carlson. The inspection revealed eight observations regarding the facility's compliance with regulations for sterile drug product manufacturing.

Key violations include: 1. **Inadequate Microbiological Contamination Prevention:** Procedures for preventing microbiological contamination of sterile drug products are not established, written, or followed. The environmental monitoring (EM) program is insufficient, lacking EM for gowns during aseptic processing, inadequate non-viable particle and active air sampling duration, and failure to detect microorganisms found in finished products. Uncapped syringe tips made direct contact with working surfaces, posing contamination risks. 2. **Lack of Secondary Review for Laboratory Records:** EM raw data recorded in Excel sheets lack a secondary review process, allowing for potential alteration and compromising data integrity. 3. **Failure to Investigate Batch Failures:** The firm did not investigate initial visual inspection failures for seven batches since 2023, where defects like black or white particles exceeded acceptable limits, even if reinspection yielded passing results. 4. **Unsound Laboratory Control Specifications:** Scientific rationale is not provided for established limits for subvisible particles in Avastin products, and particulate matter specifications differ between products (e.g., Avastin vs. Lidocaine HCL 2% Injection) without justification. 5. **Deficient