Overview
- 13 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-06-04.
At a glance
Inspections
13
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Jun 2021 – 4 Jun 2021 | Biologics | Clean | |
| 14 Aug 2018 – 15 Aug 2018 | Biologics | Clean | |
| 7 Mar 2016 – 9 Mar 2016 | Biologics | Clean | |
| 13 Oct 2015 – 15 Oct 2015 | Biologics | Clean | |
| 28 Aug 2014 – 12 Sep 2014 | Biologics | 483 | On file |
| 5 Sep 2013 – 17 Sep 2013 | Biologics | 483 | View 483 → |
| 25 Jul 2012 | Not recorded | Clean | |
| 27 Apr 2010 | Not recorded | 483 | View 483 → |
| 21 Mar 2008 | Not recorded | 483 | On file |
| 23 May 2007 | Not recorded | Clean | |
| 31 Mar 2005 | Not recorded | Clean | |
| 22 Mar 2004 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Matthew J Gretkierewicz3 insp.
Kelley L Clark3 insp.
Crystal M Young-Lewis2 insp.
Barbara A Rusin2 insp.
Jennifer A Kemp1 insp.
Bleta Vuniqi1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 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 |
| 21 CFR 606.40(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind American National Red Cross Great Lakes Region's 4 Form 483s
Source PDFs, 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