RC Outsourcing LLC
Form 483 issued September 27, 2024 · Lowellville, Ohio
- Inspection
- Sep 17 – Sep 27, 2024
- Investigator
- Taichun Qin
- Observations
- 8
- Pages
- 9
In short: On September 27, 2024, FDA issued a Form 483 with 8 observations to RC Outsourcing LLC in Lowellville, Ohio after an inspection that ran Sep 17 – Sep 27, 2024. The investigator was Taichun Qin. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production 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 are not…
- 02
Laboratory records do not include the initials or signature of a second person showing that the…
- 03
There is a failure to thoroughly review the failure of a batch or any of its…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
This inspection in context
Taichun Qin
35 documents · 2017–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
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
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 laboratory controls, production and quality system. The opening words of each observation are shown on this page.
Who inspected RC Outsourcing LLC?
Taichun Qin is named on this Form 483, for the inspection of Sep 17 – Sep 27, 2024. Each investigator has a profile showing what they cite most.
When was RC Outsourcing LLC inspected by FDA?
The inspection ran Sep 17 – Sep 27, 2024, and the Form 483 is dated September 27, 2024.
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.