Overview
- 9 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2025-07-21.
At a glance
Inspections
9
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Jul 2025 | Biologics | Clean | |
| 31 Jul 2023 | Biologics | Clean | |
| 23 Jul 2018 | Biologics | Clean | |
| 23 May 2016 | Biologics | Clean | |
| 21 Feb 2014 | Biologics | Clean | |
| 4 Jun 2012 | Not recorded | Clean | |
| 8 Jun 2011 | Not recorded | 483 | View 483 → |
| 21 Sep 2009 | Not recorded | Clean | |
| 8 Aug 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Jun 2011
21 CFR 606.65(e)
Following manufacturer's instructions
Cited by Mark W Babbitt, Dianna D Wardlow-Dotter
8 Jun 2011
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Mark W Babbitt, Dianna D Wardlow-Dotter
Investigators
FDA investigators tied to this site in the record.
Mark W Babbitt4 insp.
Kaarin M Slotte1 insp.
Sunitha K Rajaram1 insp.
Ismael Olvera-Iv1 insp.
Dianna D Wardlow-Dotter1 insp.
Dolores E Price1 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 |
| 21 CFR 606.65(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind The American National Red Cross' 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