RC Outsourcing LLC
Form 483 issued August 28, 2025 · Lowellville, Ohio
- Inspection
- Aug 18 – Aug 28, 2025
- Investigator
- Margaret M. Ames
- Observations
- 8
- Pages
- 8
- FEI number
- 3011967886
In short: On August 28, 2025, FDA issued a Form 483 with 8 observations to RC Outsourcing LLC in Lowellville, Ohio (FEI 3011967886) after an inspection that ran Aug 18 – Aug 28, 2025. The investigator was Margaret M. Ames. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
Investigations of a failure of a batch or any of its components to meet any of…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
This inspection in context
Margaret M. Ames
1 document · 2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Ohio.
The firmRC Outsourcing LLC history
All 9 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
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 quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected RC Outsourcing LLC?
Margaret M. Ames is named on this Form 483, for the inspection of Aug 18 – Aug 28, 2025. Each investigator has a profile showing what they cite most.
When was RC Outsourcing LLC inspected by FDA?
The inspection ran Aug 18 – Aug 28, 2025, and the Form 483 is dated August 28, 2025.
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.