RC Outsourcing LLC
Form 483 issued September 23, 2022 · Lowellville, Ohio
- Inspection
- Aug 31 – Sep 23, 2022
- Investigator
- Ucheabuchi C. Chudi-Nwankwor
- Observations
- 10
- Pages
- 10
- FEI number
- 3011967886
In short: On September 23, 2022, FDA issued a Form 483 with 10 observations to RC Outsourcing LLC in Lowellville, Ohio (FEI 3011967886) after an inspection that ran Aug 31 – Sep 23, 2022. The investigator was Ucheabuchi C. Chudi-Nwankwor. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 7 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Protective apparel is not worn as necessaiy to protect…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Ucheabuchi C. Chudi-Nwankwor
22 documents · 2016–2026
Cites 211.22 (responsibilities of quality control unit) 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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at RC Outsourcing LLC?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected RC Outsourcing LLC?
Ucheabuchi C. Chudi-Nwankwor is named on this Form 483, for the inspection of Aug 31 – Sep 23, 2022. Each investigator has a profile showing what they cite most.
When was RC Outsourcing LLC inspected by FDA?
The inspection ran Aug 31 – Sep 23, 2022, and the Form 483 is dated September 23, 2022.
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.