FDA Intel

Utah Medical Products, Inc.

Form 483 issued July 23, 2015 · Midvale, Utah

Observations
7
Pages
2
FEI number
1718873

In short: On July 23, 2015, FDA issued a Form 483 with 7 observations to Utah Medical Products, Inc. in Midvale, Utah (FEI 1718873). Most observations concern cAPA and production & process controls.

At a glance

Observations span 2 systems, led by capa.

CAPA2
Production & process controls1
Other4

What FDA observed

Preview: the opening words of each observation

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

  1. 01
    21 CFR 820.100

    Observation 1: scanned text, readable in the full document.

  2. 02
    21 CFR 820.8021 CFR 820.184

    Review of the firm's Device History Records (DHR.s) for the intran Plus Cathethers…

  3. 03

    Validation ,;rudics hav<.: no< ~)cen condl:c:ed t'or the manufacruring proces~ of the lntran P:us products to…

  4. 04
    21 CFR 820.90

    Observation 4: scanned text, readable in the full document.

3 more observations

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

Get the full 483

This inspection in context

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.

Questions about this 483

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

FDA listed 7 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.

When was Utah Medical Products, Inc. inspected by FDA?

This Form 483 is dated July 23, 2015.

How do I get the full Form 483 for Utah Medical Products, Inc.?

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