Utah Medical Products, Inc.

Form 483 issued August 1, 2001 · Midvale, Utah

Inspection: Jun 4 – Aug 1, 2001
Investigator: T. H. Detaley
Observations: 6
Pages: 2
FEI number: 1718873

In short: On August 1, 2001, FDA issued a Form 483 with 6 observations to Utah Medical Products, Inc. in Midvale, Utah (FEI 1718873) after an inspection that ran Jun 4 – Aug 1, 2001. The investigator was T. H. Detaley. Most observations concern cAPA and production & process controls.

At a glance

CAPA and production & process controls account for 4 of 6 observations.

CAPA2

Production & process controls2

Other2

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

01
21 CFR 820.100
Review of the firm's corrective and…
02
21 CFR 820.80 21 CFR 820.184
Review of the firm's Device History Records (DHRs) for the Intran Plus Cathethers…
03
21 CFR 820.75
Validation studies have not been conducted for the manufacturing process of the Intran Plus products to…
04
21 CFR 820.90
Review of the firm's Non-Conforming Material…

2 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

The investigator

T. H. Detaley

1 document · 2001

Cites 11.10 (controls for closed systems) more than any other section. Most of their documents are for sites in Utah.

The firm

Utah Medical Products, Inc. history

All 10 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 820.100

See how FDA wrote the same problem up elsewhere.

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Inspection report for this inspectionJun 8, 2001$550

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Questions about this 483

What did FDA find at Utah Medical Products, Inc.?

FDA listed 6 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.

Who inspected Utah Medical Products, Inc.?

T. H. Detaley is named on this Form 483, for the inspection of Jun 4 – Aug 1, 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 – Aug 1, 2001, and the Form 483 is dated August 1, 2001.

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.