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

Source: https://www.keypedia.com/records/483/rc-outsourcing-llc/e002c475-7b79-42ee-a975-e5d639a81873

> 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: Cincinnati District Office
- Summary: RC Outsourcing LLC, an outsourcing facility in Lowellville, OH, was inspected regarding its sterile drug repackaging operations. The inspection revealed significant deficiencies in aseptic processing, environmental monitoring, quality control unit responsibilities, and equipment calibration. Additionally, the firm failed to submit adverse event reports to the FDA in a timely manner.

## Related Documents

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- [483 - 2019-02-08](https://www.keypedia.com/records/483/rc-outsourcing-llc/371b0dd6-8a3a-4b92-b260-2c5cc34c7717)

## Related Officers

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

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