Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2012-06-21.
At a glance
Inspections
5
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Jun 2012 | Not recorded | Clean | |
| 7 Oct 2010 | Not recorded | 483 | View 483 → |
| 19 Jun 2008 | Not recorded | Clean | |
| 5 Dec 2005 | Not recorded | Clean | |
| 6 Dec 1999 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Oct 2010
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Janae D Price, Debra Boyd Seale
7 Oct 2010
21 CFR 606.160(a)(2)
Determination of lot numbers and supplies
Cited by Janae D Price, Debra Boyd Seale
7 Oct 2010
21 CFR 610.47
Notification of transfusion recipients
Cited by Janae D Price, Debra Boyd Seale
7 Oct 2010
21 CFR 640.3(a)(1)
Donor suitability procedures not followed
Cited by Janae D Price, Debra Boyd Seale
Investigators
FDA investigators tied to this site in the record.
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 | 1x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 610.47 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.3(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Edward Hospital Blood Bank's 1 Form 483
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