Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2020-03-12.
At a glance
Inspections
1
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Feb 2020 – 12 Mar 2020 | Biologics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Mar 2020
21 CFR 1271.47(a)
Testing, screening, donor eligibility procedures
Cited by Travis S Bradley, Abby L Mozeke-Baker
12 Mar 2020
21 CFR 1271.47(a)
Testing, screening, donor eligibility procedures
Cited by Travis S Bradley, Abby L Mozeke-Baker
12 Mar 2020
21 CFR 1271.50(a)
Determination based on screening and testing
Cited by Travis S Bradley, Abby L Mozeke-Baker
Investigators
FDA investigators tied to this site in the record.
Travis S Bradley1 insp.
Abby L Mozeke-Baker1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.290(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.50(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.55(d)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.80(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.85(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind One Umbilical Cord Lab, Inc.'s 1 Form 483
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