Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-01-06.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Jan 2023 – 6 Jan 2023 | Biologics | 483 | View 483 → |
| 1 Feb 2021 – 11 Feb 2021 | Biologics | 483 | View 483 → |
| 8 Jan 2018 – 12 Jan 2018 | Biologics | Clean | |
| 26 Jun 2014 | Biologics | Clean | |
| 3 Mar 2011 | Not recorded | Clean | |
| 13 May 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Jan 2023
21 CFR 1271.260(a)
Contamination, mix ups, improper release
Cited by Laurissa S Flowers, William F Lagud, Emily B Camire
11 Feb 2021
21 CFR 1271.160(d)
Computer software verification
Cited by Laurissa S Flowers, Abby L Mozeke-Baker
11 Feb 2021
21 CFR 1271.180(a)
Procedures to meet core CTGP
Cited by Laurissa S Flowers, Abby L Mozeke-Baker
11 Feb 2021
21 CFR 1271.230(a)
Process validation procedures
Cited by Laurissa S Flowers, Abby L Mozeke-Baker
11 Feb 2021
21 CFR 1271.270(b)
Management system, other records
Cited by Laurissa S Flowers, Abby L Mozeke-Baker
Investigators
FDA investigators tied to this site in the record.
Marion W Nadeau3 insp.
Laurissa S Flowers2 insp.
William F Lagud1 insp.
Emily B Camire1 insp.
Abby L Mozeke-Baker1 insp.
Marc A Jackson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.160(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.180(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.230(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.260(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.270(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.75(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.85(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Utah Cord Bank, Incorporated's 2 Form 483s
Source PDFs 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