Overview
- 9 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-04-12.
At a glance
Inspections
9
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Apr 2019 – 12 Apr 2019 | Biologics | Clean | |
| 28 Aug 2017 – 31 Aug 2017 | Biologics | Clean | |
| 15 Jun 2015 – 26 Jun 2015 | Biologics | 483 | View 483 → |
| 11 Aug 2014 – 26 Sep 2014 | Biologics | 483 | View 483 → |
| 16 Jul 2013 – 2 Aug 2013 | Biologics | 483 | View 483 → |
| 31 Jul 2012 | Not recorded | Clean | |
| 23 Apr 2010 | Not recorded | 483 | View 483 → |
| 16 Mar 2009 | Not recorded | Clean | |
| 25 Apr 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Jun 2015
21 CFR 606.100(b)
Maintained and followed
Cited by Susan M Miller, Denise L Burosh, Melissa D Kalik
26 Jun 2015
21 CFR 606.160(b)
Required records
Cited by Susan M Miller, Denise L Burosh, Melissa D Kalik
26 Jun 2015
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Susan M Miller, Denise L Burosh, Melissa D Kalik
26 Sep 2014
21 CFR 606.40
Clean & orderly
Cited by Sandra Sejdinovic, Kellie L Thommes, Susan M Miller, Kellie L Westerbuhr
26 Sep 2014
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Sandra Sejdinovic, Kellie L Thommes, Susan M Miller, Kellie L Westerbuhr
Investigators
FDA investigators tied to this site in the record.
Susan M Miller5 insp.
Melissa D Kalik3 insp.
Denise L Burosh2 insp.
Karen M Labounty2 insp.
Ellen C Weisensel2 insp.
Susan M North1 insp.
Lauren M Lilly1 insp.
Travis S Bradley1 insp.
Sandra Sejdinovic1 insp.
Kellie L Thommes1 insp.
Kellie L Westerbuhr1 insp.
Melissa J Holz1 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 | 5x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.40 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind American National Red Cross (The)'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