RC Outsourcing LLC
Form 483 issued February 8, 2019 · Lowellville, Ohio
- Inspection
- Jan 14 – Feb 8, 2019
- Investigator
- Robert M. Barbosa
- Observations
- 8
- Pages
- 5
- FEI number
- 3011967886
In short: On February 8, 2019, FDA issued a Form 483 with 8 observations to RC Outsourcing LLC in Lowellville, Ohio (FEI 3011967886) after an inspection that ran Jan 14 – Feb 8, 2019. The investigator was Robert M. Barbosa. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and production account for 5 of 8 observations.
Most cited: 21 CFR 211.165 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written production and process control procedures are not followed in the execution of production…
- 02
There is no written testing program designed to assess the stability…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Robert M. Barbosa
13 documents · 2013–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Indiana.
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 211.165
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 most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected RC Outsourcing LLC?
Robert M. Barbosa is named on this Form 483, for the inspection of Jan 14 – Feb 8, 2019. Each investigator has a profile showing what they cite most.
When was RC Outsourcing LLC inspected by FDA?
The inspection ran Jan 14 – Feb 8, 2019, and the Form 483 is dated February 8, 2019.
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.