Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-09-15.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Sep 2023 – 15 Sep 2023 | Biologics | 483 | View 483 → |
| 13 Jan 2020 – 17 Jan 2020 | Biologics | 483 | View 483 → |
| 15 Mar 2018 – 22 Mar 2018 | Biologics | 483 | On file |
| 7 Dec 2015 – 11 Dec 2015 | Biologics | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Sep 2023
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Nancy L Neiger, Lauren M Lilly
Investigators
FDA investigators tied to this site in the record.
Nancy L Neiger2 insp.
Gene D Arcy2 insp.
Lauren M Lilly1 insp.
Nimmy Mathews1 insp.
Simone E Pitts1 insp.
Prajakta A Varadkar1 insp.
Michele L Forster1 insp.
Chad R Burger1 insp.
Qiao Y Bobo1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.42(c)(10)(iv) | 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 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.12(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Cleveland Cord Blood Center's 4 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