University of Missouri System
Form 483 issued August 15, 2019 · Columbia, Missouri
- Inspection
- Aug 14 – Aug 15, 2019
- Investigators
- Jonathan G. Gayeshuway· Simone E. Pitts
- Observations
- 1
- Pages
- 2
- FEI number
- 1926520
In short: On August 15, 2019, FDA issued a Form 483 with 1 observation to University of Missouri System in Columbia, Missouri (FEI 1926520) after an inspection that ran Aug 14 – Aug 15, 2019. The investigators were Jonathan G. Gayeshuway and Simone E. Pitts. Most observations concern quality system; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.180 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Records are not maintained so that the data therein can be reviewed at least annually to…
This inspection in context
Jonathan G. Gayeshuway
1 document · 2019
Cites 211.180 (general requirements) more than any other section. Most of their documents are for sites in Missouri.
The firmUniversity of Missouri System history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.180
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at University of Missouri System?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
Who inspected University of Missouri System?
Jonathan G. Gayeshuway and Simone E. Pitts are named on this Form 483, for the inspection of Aug 14 – Aug 15, 2019. Each investigator has a profile showing what they cite most.
When was University of Missouri System inspected by FDA?
The inspection ran Aug 14 – Aug 15, 2019, and the Form 483 is dated August 15, 2019.
How do I get the full Form 483 for University of Missouri System?
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.