Overview
- 7 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2024-10-03.
At a glance
Inspections
7
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Oct 2024 | Biologics | Clean | |
| 12 Sep 2019 | Biologics | Clean | |
| 6 Mar 2017 | Biologics | Clean | |
| 18 Dec 2014 – 29 Dec 2014 | Biologics | 483 | View 483 → |
| 7 Jan 2013 | Not recorded | Clean | |
| 3 Jan 2011 | Not recorded | Clean | |
| 26 Feb 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Dec 2014
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Barbara A Rusin
Investigators
FDA investigators tied to this site in the record.
Matthew J Gretkierewicz2 insp.
Barbara A Rusin2 insp.
Neali H Lucas2 insp.
Erma Zaimova1 insp.
Sherri J Jackson1 insp.
Gary D Urbiel Goldner1 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 |
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