Utah Medical Products, Inc.
FDA inspection history across 2 sites, 2001 to 2015
- 5
- Form 483s
- 4
- EIRs
- 1
- Warning letter
Every document, by year
- Form 483
- EIR
- Warning letter
2001: one warning letter, one Form 483 and one inspection report; 2002: one inspection report and one Form 483; 2003: one inspection report and one Form 483; 2004: one inspection report and one Form 483; 2015: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2001–04Four Form 483s, four inspection reports and one warning letter, at Midvale, Utah and Salt Lake City, Utah.
- 2003The longest 483 on file: 19 observations over 14 pages at Midvale, Utah.
- 2015One Form 483, at Midvale, Utah.
Cited most
Across all Utah Medical Products observations on file
- 21 CFR 820.100Corrective and preventive action8
- 21 CFR 820.184Device history record4
- 21 CFR 820.70Production and process controls4
- 21 CFR 820.75Process validation4
- 21 CFR 820.80Receiving, in-process, and finished device acceptance4
The complete Utah Medical Products file.
All 10 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
25% off buying them one by one
Sites
Midvale, Utah
Four Form 483s, four inspection reports and one warning letter · 2001 to 2015 · 46 observations
Latest: Form 483, Jul 23, 2015 →Salt Lake City, Utah
One Form 483 · 2002 · 13 observations
Latest: Form 483, Apr 15, 2002 →
Documents
10 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-07-23 | 483 Form 483 | Midvale, Utah | 7 | $99 |
| 2004-03-03 | EIR EIR | Midvale, Utah | — | $550 |
| 2004-03-03 | 483 Form 483 | Midvale, Utah | 7 | $99 |
| 2003-03-12 | EIR EIR | Midvale, Utah | — | $550 |
| 2003-03-12 | 483 Form 483 | Midvale, Utah | 19 | $99 |
| 2002-04-18 | EIR EIR | Midvale, Utah | — | $550 |
| 2002-04-15 | 483 Form 483 | Salt Lake City, Utah | 13 | $99 |
| 2001-09-04 | Warning letter Warning letter | Midvale, Utah | — | $99 |
| 2001-08-01 | 483 Form 483 | Midvale, Utah | 6 | $99 |
| 2001-06-08 | EIR EIR | Midvale, Utah | 7 | $550 |
Investigators on these documents
Ricki A. Chase-Off (3)Ralph W. Jerkdal (2)Lori A. Medina (2)Monica J. Wilkins (2)Blvin R. Smith (1)Thai Duong (1)Karen A. Coleman (1)Karen A. Coleun (1)T. H. Detaley (1)
FEI number 1718873 · most recent document Jul 23, 2015
About Utah Medical Products, Inc.
How many FDA Form 483s has Utah Medical Products, Inc. received?
FDA Intel has 5 Form 483s on file for Utah Medical Products, Inc.; the most recent is dated Jul 23, 2015.
When was Utah Medical Products, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Utah Medical Products, Inc. is a Form 483 dated Jul 23, 2015, for the site in Midvale, Utah.
What did FDA cite at Utah Medical Products, Inc.?
The regulations cited most in the observations on file for Utah Medical Products, Inc. are 21 CFR 820.100 (Corrective and preventive action), 8 times; 21 CFR 820.184 (Device history record), 4 times; 21 CFR 820.70 (Production and process controls), 4 times.
Has Utah Medical Products, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Utah Medical Products, Inc.; the most recent is dated Sep 4, 2001.