Radix Laboratories Incorporated
Form 483 issued July 25, 2019 · Eau Claire, Wisconsin
- Inspection
- Jun 19 – Jul 25, 2019
- Investigator
- James K. Ireland
- Observations
- 3
- Pages
- 3
- FEI number
- 2129004
In short: On July 25, 2019, FDA issued a Form 483 with 3 observations to Radix Laboratories Incorporated in Eau Claire, Wisconsin (FEI 2129004) after an inspection that ran Jun 19 – Jul 25, 2019. The investigator was James K. Ireland. 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 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Procedures designed to prevent objectionable microorganisms in diug products not required to be…
- 03
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
James K. Ireland
10 documents · 2016–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Minnesota.
The firmRadix Laboratories Incorporated history
The site's inspection history, in date order.
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 Radix Laboratories Incorporated?
FDA listed 3 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 Radix Laboratories Incorporated?
James K. Ireland is named on this Form 483, for the inspection of Jun 19 – Jul 25, 2019. Each investigator has a profile showing what they cite most.
When was Radix Laboratories Incorporated inspected by FDA?
The inspection ran Jun 19 – Jul 25, 2019, and the Form 483 is dated July 25, 2019.
How do I get the full Form 483 for Radix Laboratories Incorporated?
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.