RC Outsourcing, LLC
Form 483 issued September 3, 2026 · Lowellville, Ohio
- Inspection
- Aug 24 – Sep 3, 2026
- Investigators
- Jeremy T. Dautrich· Kara J. Wright· Pushpa S. Jayasekara
- Observations
- 8
- Pages
- 13
- FEI number
- 3011967
In short: On September 3, 2026, FDA issued a Form 483 with 8 observations to RC Outsourcing, LLC in Lowellville, Ohio (FEI 3011967) after an inspection that ran Aug 24 – Sep 3, 2026. The investigators were Jeremy T. Dautrich, Kara J. Wright and Pushpa S. Jayasekara. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the…
- 04
There is a lack of written procedures assigning responsibility, providing cleaning schedules and describing in sufficient…
This inspection in context
Jeremy T. Dautrich
1 document · 2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ohio.
The firmRC Outsourcing, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at RC Outsourcing, LLC?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected RC Outsourcing, LLC?
Jeremy T. Dautrich, Kara J. Wright and Pushpa S. Jayasekara are named on this Form 483, for the inspection of Aug 24 – Sep 3, 2026. Each investigator has a profile showing what they cite most.
When was RC Outsourcing, LLC inspected by FDA?
The inspection ran Aug 24 – Sep 3, 2026, and the Form 483 is dated September 3, 2026.
How do I get the full Form 483 for RC Outsourcing, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.