Overview
- 13 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-07-27.
At a glance
Inspections
13
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Jul 2023 | Biologics | Clean | |
| 29 Aug 2018 | Biologics | Clean | |
| 7 Jun 2016 – 8 Jun 2016 | Biologics | Clean | |
| 20 Jan 2015 – 21 Jan 2015 | Biologics | Clean | |
| 15 Jul 2014 – 21 Jul 2014 | Biologics | Clean | |
| 13 Aug 2013 – 15 Aug 2013 | Biologics | Clean | |
| 19 Jul 2012 | Not recorded | Clean | |
| 29 Mar 2011 | Not recorded | 483 | On file |
| 23 Jul 2009 | Not recorded | Clean | |
| 6 Oct 2008 | Not recorded | 483 | View 483 → |
| 23 Sep 2005 | Not recorded | Clean | |
| 13 Oct 2004 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Oct 2008
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by William D Bassett
Investigators
FDA investigators tied to this site in the record.
Paula J Bretz3 insp.
William D Bassett2 insp.
Jennifer L Sheehan1 insp.
Leena Thomas1 insp.
Brandon L Mariner1 insp.
Travis R Hunt1 insp.
Barbara A Rusin1 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 | 1x |
Full site report
Get the verbatim findings behind The American National Red Cross' 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