RC Outsourcing LLC
Amended 483 issued February 9, 2016 · Lowellville, Ohio
- Inspection
- Jan 25 – Feb 9, 2016
- Investigator
- Joshua P. Wireman
- Observations
- 8
- Pages
- 6
- FEI number
- 3011967886
In short: On February 9, 2016, FDA issued a Amended 483 with 8 observations to RC Outsourcing LLC in Lowellville, Ohio (FEI 3011967886) after an inspection that ran Jan 25 – Feb 9, 2016. The investigator was Joshua P. Wireman. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to…
- 02
Procedures designed to prevent microbiological contamination of dmg products pmporting to be sterile…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
There is a failure to thoroughly review any llllexplained discrepancy whether or not the batch…
4 more observations
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Joshua P. Wireman
8 documents · 2015–2019
Cites 211.42 (design and construction features) 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 documentsOther sites cited under 211.167(a)
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at RC Outsourcing LLC?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. 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?
Joshua P. Wireman is named on this Amended 483, for the inspection of Jan 25 – Feb 9, 2016. Each investigator has a profile showing what they cite most.
When was RC Outsourcing LLC inspected by FDA?
The inspection ran Jan 25 – Feb 9, 2016, and the Amended 483 is dated February 9, 2016.
How do I get the full Amended 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.