FDA 483 - RC Outsourcing, LLC - August 28, 2025

**FDA 483 Summary: RC Outsourcing, LLC**

**Inspection Dates:** August 18-28, 2025 **Company:** RC Outsourcing, LLC **Location:** 102 E Water St, Lowellville, OH 44436-1117 **Contact:** Raymond R. Carlson, RPh, Owner

**Main Violations/Issues:**

1. **Failure to Extend Investigations:** The firm did not extend investigations of a failed batch of Avastin® (bevacizumab) to other batches re-packaged by the same technician, despite identifying a potential root cause related to the technician"s unreported medical condition.

2. **Aseptic Processing Deficiencies:** The facility lacks a scientifically sound environmental monitoring plan. The placement of air sampling equipment and passive air plates is not representative of ISO 5 conditions, and the use of inappropriate sampling plates was noted. Personnel monitoring techniques were inadequate, and action levels for microbial recovery were not justified or investigated.

3. **Unexplained Discrepancies Not Reviewed:** Approximately 43 instances of microbial recovery on personnel sleeves were not investigated, despite indicating a potential adverse trend.

4. **Microbiological Contamination Prevention:** Procedures to prevent contamination during the re-packaging of Povidone-Iodine were not followed, with tips and caps placed directly on surfaces, repeating issues from a previous inspection.

5. **Laboratory Control Deficiencies:** Test methods for certain ointments were not validated, with contract lab analyses not meeting cGMP standards.

**Regulatory Framework:** The observations are based on FDA regulations for outsourcing facilities, focusing on sterility, environmental monitoring, and laboratory controls.

**Required Actions:** RC Outsourcing must address these deficiencies by extending batch investigations, developing a robust environmental monitoring plan, reviewing microbial recovery trends, adhering to contamination prevention protocols, and ensuring laboratory test methods are validated. Immediate corrective actions and documentation of compliance improvements are necessary to meet FDA standards.