Overview
- 11 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-06.
At a glance
Inspections
11
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Aug 2025 | Biologics | Clean | |
| 27 Jul 2023 | Biologics | Clean | |
| 8 Aug 2018 | Biologics | Clean | |
| 2 Jun 2016 | Biologics | Clean | |
| 15 May 2014 | Biologics | 483 | View 483 → |
| 12 Sep 2012 | Not recorded | 483 | View 483 → |
| 20 Jul 2010 | Not recorded | Clean | |
| 6 Feb 2008 | Not recorded | Clean | |
| 5 Mar 2004 | Not recorded | Clean | |
| 3 Aug 2001 | Not recorded | Clean | |
| 31 Mar 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
15 May 2014
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Mark W Babbitt
12 Sep 2012
21 CFR 606.160(a)(1)
Person performing, test results, interpretation
Cited by Julian C Hanson, Peter S Kessler
Investigators
FDA investigators tied to this site in the record.
Ismael Olvera-Iv2 insp.
Mark W Babbitt2 insp.
Alan R Condon1 insp.
Julian C Hanson1 insp.
Peter S Kessler1 insp.
Donald W Jehn1 insp.
Dolores E Price1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Providence Health & Services Montana's 2 Form 483s
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