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

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