MRIGlobal
Form 483 issued August 29, 2022 · Kansas City, Missouri
- Inspection
- Aug 24 – Aug 29, 2022
- Investigators
- Gretchen L. Trendel· Torrey M. Ward
- Observations
- 1
- Pages
- 3
- FEI number
- 1917659
In short: On August 29, 2022, FDA issued a Form 483 with 1 observation to MRIGlobal in Kansas City, Missouri (FEI 1917659) after an inspection that ran Aug 24 – Aug 29, 2022. The investigators were Gretchen L. Trendel and Torrey M. Ward. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written records of investigations into unexplained discrepancies do not always include…
This inspection in context
Gretchen L. Trendel
6 documents · 2021–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Kansas.
The firmMRIGlobal history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MRIGlobal?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected MRIGlobal?
Gretchen L. Trendel and Torrey M. Ward are named on this Form 483, for the inspection of Aug 24 – Aug 29, 2022. Each investigator has a profile showing what they cite most.
When was MRIGlobal inspected by FDA?
The inspection ran Aug 24 – Aug 29, 2022, and the Form 483 is dated August 29, 2022.
How do I get the full Form 483 for MRIGlobal?
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.