# FDA 483 - RC Outsourcing, LLC - February 08, 2019

Source: https://www.keypedia.com/records/483/rc-outsourcing-llc/371b0dd6-8a3a-4b92-b260-2c5cc34c7717

> FDA 483 for RC Outsourcing, LLC on February 08, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RC Outsourcing, LLC
- Inspection Date: 2019-02-08
- Product Type: Drugs
- Office Name: Detroit District Office
- Summary: The FDA Form 483 details multiple deficiencies at a drug manufacturing facility.

**Violations and Observations:**

*   **Failure to follow written procedures:**
    *   Vancomycin HCl USP 1mg/0.1ml lot no. 03092018 had a reported pH of 6.97, exceeding the specified (b)(4) range. This OOS pH was linked to two complaints of cloudiness due to vancomycin precipitation.
    *   The firm's Quality review failed to identify this pH OOS event before lot release.
    *   Inadequate CAPAs were implemented to address the Quality unit's failure to observe the OOS event.
*   **Lack of a written stability testing program:**
    *   No adequate data (published literature or test studies) supports the BUD/Expiration dates for products.
*   **Failure to thoroughly investigate discrepancies:**
    *   No investigation was conducted for 70 syringe defect complaints (bent/dull/clogged needles, stuck plungers, empty syringes) received between April 1, 2017, and December 31, 2018.
*   **Inadequate drug product testing and release:**
    *   Identity and strength (potency) testing was not performed for each lot of Cefuroxime 1mg, Moxifloxacin 1.5mg

## Related Documents

- [483 - 2017-03-31](https://www.keypedia.com/records/483/rc-outsourcing-llc/50513142-bcd1-4654-9349-6ec3e95d039b)
- [483 - 2016-02-09](https://www.keypedia.com/records/483/rc-outsourcing-llc/a24ce01a-050f-46d0-aca3-4e03fe744495)
- [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/7ad607ec-eedb-492a-9ddd-83ab9dddd0eb)

## Related Officers

- [Investigator](https://www.keypedia.com/people/robert-burbosa/4959685c-a015-4dc7-b554-01a4f856e845)

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

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03