Atlas

FDA-Inspected Site

Intermountain Health Lutheran Hospital

11 FDA inspections are on record for Intermountain Health Lutheran Hospital in Wheat Ridge, United States.

483· Form 483 issued

Wheat Ridge, United States · Last updated July 10, 2026

Overview

  • 11 FDA inspections are on record.
  • 6 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-04-28.

At a glance

Inspections

11

Form 483s

6

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
24 Apr 2026 – 28 Apr 2026Biologics483On file
16 Mar 2023 – 21 Mar 2023Biologics483On file
14 Aug 2018 – 15 Aug 2018BiologicsClean
12 Jan 2016 – 19 Jan 2016Biologics483View 483 →
17 Mar 2014 – 19 Mar 2014BiologicsClean
14 Jan 2013Not recorded483View 483 →
3 Nov 2010Not recordedClean
1 Jul 2009Not recorded483View 483 →
1 May 2008Not recorded483On file
4 Mar 2004Not recordedClean
28 Sep 2000Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

19 Jan 2016
21 CFR 606.100(b)

Maintained and followed

Cited by Carla R Hinz

19 Jan 2016
21 CFR 606.171

Biological product deviation report

Cited by Carla R Hinz

19 Jan 2016
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Carla R Hinz

14 Jan 2013
21 CFR 211.68(a)

Calibration/Inspection/Checking not done

Cited by Carla R Hinz

14 Jan 2013
21 CFR 600.14(a)(1)

Who must report - manufacturer

Cited by Carla R Hinz

Investigators

FDA investigators tied to this site in the record.

Carla R Hinz2 insp.
Daniel P Stlaurent2 insp.
Deepa E Vadakkan1 insp.
Gloria A Milster1 insp.
Kelly D Moore1 insp.
Kristen E Szenderski1 insp.
Randy V Bong1 insp.
Bryan J Love1 insp.
Theressa B Smith1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 606.100(b)Cited across public-safe Form 483 observations2x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x
21 CFR 600.14(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 606.170(a)Cited across public-safe Form 483 observations1x
21 CFR 606.171Cited across public-safe Form 483 observations1x
21 CFR 606.65(c)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Intermountain Health Lutheran Hospital's 6 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat