FDA 483 - RC Outsourcing, LLC - September 23, 2022

This FDA Form 483 was issued to RC Outsourcing LLC, an outsourcing facility located at 102 E Water St, Lowellville, OH, following an inspection from August 31, 2022, to September 23, 2022. Ray R. Carlson is the Owner/CEO.

The inspection revealed ten observations related to significant deficiencies in sterile drug product manufacturing and quality systems:

1. **Microbiological Contamination Prevention:** Procedures to prevent microbiological contamination of sterile drug products are not established, written, or followed. This includes inadequate hand sanitization practices, blocking first-pass air in ISO 5 areas, an aseptic operator touching a plunger during operations for a distributed lot, technicians moving between ISO 7 and ISO 8 areas without changing gloves or gowns, and unsanitized material housings. Aseptic process simulations (media fills) were inadequate and did not simulate worst-case conditions, resulting in unqualified technicians.

2. **Protective Apparel:** Aseptic technicians did not wear protective goggles during ISO 5 Hood operations, exposing skin around the eyes.

3. **Cleaning and Disinfection:** The system for cleaning and disinfecting aseptic processing areas is deficient. Cleaning logs lack documented contact times for sporicidal agents, and an un-cleanable, non-specified device (b)(4) was touched by operators without subsequent hand sanitization before aseptic operations.

4. **Environmental Monitoring