# FDA 483 - RC Outsourcing, LLC - February 09, 2016

Source: https://www.keypedia.com/records/483/rc-outsourcing-llc/a24ce01a-050f-46d0-aca3-4e03fe744495

> FDA 483 for RC Outsourcing, LLC on February 09, 2016. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: RC Outsourcing, LLC
- Inspection Date: 2016-02-09
- Product Type: Drugs
- Office Name: Cincinnati District Office
- Summary: The FDA Form 483 inspection revealed multiple deficiencies at an outsourcing facility manufacturing sterile and pyrogen-free drug products.

**Key Violations and Observations:**

*   **Sterility Testing:** Each batch of injectable product is not tested for endotoxin, failing to confirm conformance to pyrogen-free requirements.
*   **Aseptic Processing & Contamination Control:**
    *   Media fill procedures (SOP P1.1.2.3) were not fully followed, specifically, a media fill challenge was incomplete during the last attempt.
    *   Differential pressure readings in aseptic processing areas were not monitored frequently or recorded.
*   **Quality System & Investigations:**
    *   Unexplained discrepancies were not thoroughly reviewed. Investigations into microbial counts exceeding environmental and personnel monitoring alert levels (e.g., 8 CFUs for a redacted sample on 12/4/15) were not documented.
    *   Procedures to investigate deviations from specified temperature and humidity ranges were absent. Deviations in humidity for the label room, anteroom, and clean room were noted but not investigated.
*   **Facility Construction:** Gaps of approximately 1 inch were present at the bottom of doors leading from a redacted room to the anteroom and from the anteroom to the clean room, hindering proper operations and cleaning.
*   **Complaint Handling:** Complaint files were not maintained.
*   **Equipment Calibration:** Routine calibration of the

## Related Documents

- [483 - 2017-03-31](https://www.keypedia.com/records/483/rc-outsourcing-llc/50513142-bcd1-4654-9349-6ec3e95d039b)
- [WARNING_LETTER - 2025-08-28](https://www.keypedia.com/records/warning_letter/rc-outsourcing-llc/744e0738-590c-4266-8802-661869721f50)
- [483 - 2024-09-27](https://www.keypedia.com/records/483/rc-outsourcing-llc/3ba1eb2c-b01f-403c-ae1a-2dbf5c6af57e)
- [483 - 2019-02-08](https://www.keypedia.com/records/483/rc-outsourcing-llc/371b0dd6-8a3a-4b92-b260-2c5cc34c7717)
- [483 - 2019-02-08](https://www.keypedia.com/records/483/rc-outsourcing-llc/7ad607ec-eedb-492a-9ddd-83ab9dddd0eb)

## Related Officers

- [Investigator](https://www.keypedia.com/people/joshua-p-wireman/1f5cca58-4a35-4b1a-b344-35820b1e58fb)

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

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22