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

Source: https://www.globalkeysolutions.net/records/483/rc-outsourcing-llc/6e585222-6558-4042-b47a-a325905ad4e5

> FDA 483 for RC Outsourcing, LLC on September 23, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RC Outsourcing, LLC
- Inspection Date: 2022-09-23
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Documents

- [483 - 2017-03-31](https://www.globalkeysolutions.net/records/483/rc-outsourcing-llc/50513142-bcd1-4654-9349-6ec3e95d039b)
- [483 - 2016-02-09](https://www.globalkeysolutions.net/records/483/rc-outsourcing-llc/a24ce01a-050f-46d0-aca3-4e03fe744495)
- [WARNING_LETTER - 2025-08-28](https://www.globalkeysolutions.net/records/warning_letter/rc-outsourcing-llc/744e0738-590c-4266-8802-661869721f50)
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## Related Officers

- [Ucheabuchi C. Chudi-nwankwor](https://www.globalkeysolutions.net/people/ucheabuchi-c-chudi-nwankwor/18b01d08-3cfd-4ace-97b2-5f54b6427661)

Company: https://www.globalkeysolutions.net/companies/rc-outsourcing-llc/7ab10074-d0f6-4d94-893d-1c75a54950cf

Office: https://www.globalkeysolutions.net/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c