RC Compounding Services, LLC
Form 483 issued February 7, 2013 · Poland, Ohio
- Inspection
- Feb 5 – Feb 7, 2013
- Investigators
- Dant Culver· Joshua S. Hunt
- Observations
- 6
- Pages
- 2
- FEI number
- 3009988995
In short: On February 7, 2013, FDA issued a Form 483 with 6 observations to RC Compounding Services, LLC in Poland, Ohio (FEI 3009988995) after an inspection that ran Feb 5 – Feb 7, 2013. The investigators were Dant Culver and Joshua S. Hunt. 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 6 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 03
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
This inspection in context
Dant Culver
2 documents · 2013–2014
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Kentucky.
The firmRC Compounding Services, LLC history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at RC Compounding Services, LLC?
FDA listed 6 observations on this Form 483, mostly about laboratory controls and production. 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 Compounding Services, LLC?
Dant Culver and Joshua S. Hunt are named on this Form 483, for the inspection of Feb 5 – Feb 7, 2013. Each investigator has a profile showing what they cite most.
When was RC Compounding Services, LLC inspected by FDA?
The inspection ran Feb 5 – Feb 7, 2013, and the Form 483 is dated February 7, 2013.
How do I get the full Form 483 for RC Compounding Services, 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.