Utah Medical Products, Inc.
Form 483 issued April 15, 2002 · Salt Lake City, Utah
- Inspection
- Mar 26, 2002
- Investigators
- Blvin R. Smith· Ricki A. Chase-Off
- Observations
- 13
- Pages
- 6
- FEI number
- 1718873
In short: On April 15, 2002, FDA issued a Form 483 with 13 observations to Utah Medical Products, Inc. in Salt Lake City, Utah (FEI 1718873) after an inspection that ran Mar 26, 2002. The investigators were Blvin R. Smith and Ricki A. Chase-Off. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
Production & process controls and capa account for 8 of 12 observations.
Most cited: 21 CFR 820.100 (3×) · 820.70 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
In (b)(4) the IUP line of devices underwent a change in catheter material. Validation…
- 02
Corrective/Preventive Action Report (CPAR) was opened on (b)(4) and closed on (b)(4) to address complaints of…
- 04
A review of the firm's Device History Records (DHR) for the Intran Plus product line revealed…
- 05
Not all significant quality data are being captured…
This inspection in context
Blvin R. Smith
1 document · 2002
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 483sOther sites cited under 820.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Utah Medical Products, Inc.?
FDA listed 13 observations on this Form 483, mostly about production & process controls, cAPA and records & documents. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Utah Medical Products, Inc.?
Blvin R. Smith and Ricki A. Chase-Off are named on this Form 483, for the inspection of Mar 26, 2002. Each investigator has a profile showing what they cite most.
When was Utah Medical Products, Inc. inspected by FDA?
The inspection ran Mar 26, 2002, and the Form 483 is dated April 15, 2002.
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.