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Primary Children's Hospital - Miller Campus FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Latest inspection VAI · Apr 24, 2025
No warning letters matched by name

Inspections 1

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Primary Children's Hospital - Miller Campus has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Primary Children's Hospital - Miller Campus" is on file. FDA has published 1 Form 483 for Primary Children's Hospital - Miller Campus.

What these totals cover: FDA records filed under the name "Primary Children's Hospital - Miller Campus" and its spelling variant "Primary Children Hospital - Miller Campus".

Latest inspection: Apr 24, 2025 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	1	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

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Primary Children's Hospital - Miller Campus Form 483s

1 Form 483 published by FDA.

Date	Document	FEI
Apr 24, 2025 · Document on fda.gov	483	3029463597

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

1 inspection on Apr 24, 2025.

Date	Site	Product	Classification	FEI
Apr 24, 2025	Lehi, UT	Biologics	Voluntary Action Indicated (VAI)	3029463597

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3029463597	Lehi, UT	1	Apr 24, 2025

Primary Children's Hospital - Miller Campus and the FDA: common questions

Has Primary Children's Hospital - Miller Campus received an FDA warning letter?

No FDA warning letter addressed to the name "Primary Children's Hospital - Miller Campus" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Primary Children's Hospital - Miller Campus received an FDA Form 483?

FDA has published 1 Form 483 for Primary Children's Hospital - Miller Campus in its reading room, the most recent dated Apr 24, 2025. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Primary Children's Hospital - Miller Campus?

The most recent FDA inspection on file ended Apr 24, 2025 at Lehi, UT and was classified VAI. FDA has 1 inspection of Primary Children's Hospital - Miller Campus on file.

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