Utah Medical Products, Inc.
Form 483 issued March 12, 2003 · Midvale, Utah
- Inspection
- Feb 24 – Mar 12, 2003
- Investigator
- Karen A. Coleun
- Observations
- 19
- Pages
- 14
- FEI number
- 1718873
In short: On March 12, 2003, FDA issued a Form 483 with 19 observations to Utah Medical Products, Inc. in Midvale, Utah (FEI 1718873) after an inspection that ran Feb 24 – Mar 12, 2003. The investigator was Karen A. Coleun. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
2 of 2 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.70 (1×) · 820.72 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
As of 3/5/03, no blueprints or diagrams were available on the water system URGE iping throughout…
- 02
There are S<. specifications and no mixing records for “><. water. 3. \ Rev Ydated ><…
This inspection in context
Karen A. Coleun
1 document · 2003
Cites 820.70 (production and process controls) 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 483sOther sites cited under 820.70
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Utah Medical Products, Inc.?
FDA listed 19 observations on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected Utah Medical Products, Inc.?
Karen A. Coleun is named on this Form 483, for the inspection of Feb 24 – Mar 12, 2003. Each investigator has a profile showing what they cite most.
When was Utah Medical Products, Inc. inspected by FDA?
The inspection ran Feb 24 – Mar 12, 2003, and the Form 483 is dated March 12, 2003.
How do I get the full Form 483 for Utah Medical Products, Inc.?
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.