Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2011-02-04.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Feb 2011 | Not recorded | 483 | View 483 → |
| 17 Jul 2009 | Not recorded | 483 | View 483 → |
| 24 Aug 2007 | Not recorded | Clean | |
| 21 May 2003 | Not recorded | Clean | |
| 28 Mar 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Jul 2009
21 CFR 600.80(c)(2)(ii)
Reporting Requirement - Periodic adv. exp. report content
Cited by Joseph W Matthews
Investigators
FDA investigators tied to this site in the record.
Tamika E Allen1 insp.
Joseph W Matthews1 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 | 2x |
| 21 CFR 600.80(c)(2)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.170(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind St Agnes Healthcare Blood Bank's 2 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