Overview
- 9 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-10.
At a glance
Inspections
9
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Apr 2026 – 10 Apr 2026 | Biologics | Clean | |
| 11 Jan 2023 – 13 Jan 2023 | Biologics | Clean | |
| 28 Nov 2017 – 30 Nov 2017 | Biologics | Clean | |
| 1 Dec 2015 – 3 Dec 2015 | Biologics | Clean | |
| 27 Dec 2013 – 16 Jan 2014 | Biologics | 483 | View 483 → |
| 1 Nov 2011 | Not recorded | 483 | View 483 → |
| 7 Jun 2010 | Not recorded | 483 | View 483 → |
| 24 Jul 2008 | Not recorded | 483 | On file |
| 10 Aug 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Jan 2014
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Kathleen S Tormey
16 Jan 2014
21 CFR 606.160(a)(1)
Person performing, test results, interpretation
Cited by Kathleen S Tormey
1 Nov 2011
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Daniel P Stlaurent
1 Nov 2011
21 CFR 606.151(e)
Procedures to maintain records of emergency transfusions
Cited by Daniel P Stlaurent
Investigators
FDA investigators tied to this site in the record.
Kelly D Moore2 insp.
Daniel P Stlaurent2 insp.
Deepa E Vadakkan1 insp.
Paul M Chefor1 insp.
Marc A Jackson1 insp.
Kathleen S Tormey1 insp.
Hanna L Potter1 insp.
Dianna D Wardlow-Dotter1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.151(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.65(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.3(b)(6) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Medical Center of the Rockies' 4 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