# FDA 483 - RC Outsourcing, LLC - March 31, 2017

Source: https://www.keypedia.com/records/483/rc-outsourcing-llc/50513142-bcd1-4654-9349-6ec3e95d039b

> FDA 483 for RC Outsourcing, LLC on March 31, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RC Outsourcing, LLC
- Inspection Date: 2017-03-31
- Product Type: Drugs
- Office Name: Cincinnati District Office
- Summary: On March 31, 2017, the FDA issued a Form 483 to RC Outsourcing LLC, an outsourcing facility located at 102 E Water St, Lowellville, OH, following an inspection conducted from March 27-31, 2017. Raymond R. Carlson is identified as the owner.

The inspection revealed nine observations:

1.  **Failure to thoroughly review unexplained discrepancies and out-of-specification results:** Between February 14, 2016, and March 10, 2017, 22 positive fingertip and surface sampling results exceeded acceptable limits, but only 5 investigations were completed, with limited or no action taken. A media fill also resulted in a positive colony count with no investigation. This is a repeat observation from a previous inspection ending February 9, 2016.

2.  **Deficiencies in aseptic processing area cleaning and disinfection:** Issues included using the same cloth for cleaning both outside and inside of an ISO 5 hood, and for cleaning both sides of a cleanroom door. The cleanroom door was repeatedly left open during and after cleaning, and personnel moved between ISO 8 and ISO 7 areas without changing gowning or gloves. Non-disinfected items were also brought into the ISO 7 cleanroom.

3.  **Inappropriate clothing for personnel:** During sterile gowning, personnel donned sterile gowns

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## Related Officers

- [Program Analyst](https://www.keypedia.com/people/jazmine-n-still/92bc804f-1f4e-46f6-8802-6a65b50f91ae)
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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