Utah Medical Products, Inc.
EIR issued June 8, 2001 · Midvale, Utah
- Inspection
- Jun 4 – Jun 8, 2001
- Investigator
- Thai Duong
- Observations
- 7
- Pages
- 16
- FEI number
- 1718873
In short: This is FDA's Establishment Inspection Report (EIR) for Utah Medical Products, Inc. in Midvale, Utah (FEI 1718873), covering the inspection of Jun 4 – Jun 8, 2001. It is the investigator's full narrative of what they examined, who they spoke to and what they found. The investigator was Thai Duong.
At a glance
CAPA and production & process controls account for 4 of 5 observations.
What the investigator recorded
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Review of the firm’s corrective and preventive action system revealed: a) Corrective and Preventive Action procedure…
- 02
Review of the firm’s Device History Records (DHEs} for the Intran Plus Cathethers…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Review of the firm’s Non-Conforming Material…
3 more observations
The full inspection report: what the investigator looked at, who they spoke to and what they found, in their own words.
Get the full EIRThis inspection in context
Thai Duong
5 documents · 2001–2025
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Utah.
The firmUtah Medical Products, Inc. history
All 10 documents on file for this site, in date order, with what was cited at each inspection.
Similar documentsOther sites cited under 820.100
See how FDA wrote the same problem up elsewhere.
Questions about this EIR
Who inspected Utah Medical Products, Inc.?
Thai Duong is named on this EIR, for the inspection of Jun 4 – Jun 8, 2001. Each investigator has a profile showing what they cite most.
When was Utah Medical Products, Inc. inspected by FDA?
The inspection ran Jun 4 – Jun 8, 2001.
How do I get the full EIR for Utah Medical Products, Inc.?
Download the original PDF from FDA Intel for $550, with no subscription. You also get an invoice PDF with the order.