Utah Medical Products, Inc.
Form 483 issued March 3, 2004 · Midvale, Utah
- Inspection
- Feb 2 – Mar 3, 2004
- Investigators
- Lori A. Medina· Monica J. Wilkins· Ralph W. Jerkdal
- Observations
- 7
- Pages
- 7
- FEI number
- 1718873
In short: On March 3, 2004, FDA issued a Form 483 with 7 observations to Utah Medical Products, Inc. in Midvale, Utah (FEI 1718873) after an inspection that ran Feb 2 – Mar 3, 2004. The investigators were Lori A. Medina, Monica J. Wilkins and Ralph W. Jerkdal. 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 6 of 7 observations.
Most cited: 21 CFR 820.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Acceptance procedures to ensure that specified requirements for in-process product are…
- 03
Software validation activities for computers or automated data processing systems used as part of production and…
- 04
The corrective and preventive procedures addressing the analysis of sources of quality data to identify existing…
This inspection in context
Lori A. Medina
2 documents · 2004
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 7 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.?
Lori A. Medina, Monica J. Wilkins and Ralph W. Jerkdal are named on this Form 483, for the inspection of Feb 2 – Mar 3, 2004. Each investigator has a profile showing what they cite most.
When was Utah Medical Products, Inc. inspected by FDA?
The inspection ran Feb 2 – Mar 3, 2004, and the Form 483 is dated March 3, 2004.
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.