Overview
- 10 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-10-11.
At a glance
Inspections
10
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 26 Sep 2023 – 11 Oct 2023 | Biologics | Clean | |
| 2 Mar 2020 – 10 Mar 2020 | Biologics | Clean | |
| 23 Oct 2017 – 26 Oct 2017 | Biologics | Clean | |
| 7 Jul 2015 – 10 Jul 2015 | Biologics | Clean | |
| 10 Jun 2013 – 24 Jun 2013 | Biologics | 483 | View 483 → |
| 20 May 2011 | Not recorded | Clean | |
| 6 Aug 2009 | Not recorded | 483 | View 483 → |
| 24 Jul 2008 | Not recorded | 483 | On file |
| 12 Jan 2007 | Not recorded | Clean | |
| 27 Oct 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Jun 2013
21 CFR 1271.47(a)
Testing, screening, donor eligibility procedures
Cited by Sandra Sejdinovic, Kellie L Thommes, Melissa D Kalik, Jessica L Johnson
24 Jun 2013
21 CFR 1271.80(c)
Manufacturer instructions not followed
Cited by Sandra Sejdinovic, Kellie L Thommes, Melissa D Kalik, Jessica L Johnson
6 Aug 2009
21 CFR 1271.47(a)
Procedures for all other requirements
Cited by Karen M Labounty, Melissa D Kalik
Investigators
FDA investigators tied to this site in the record.
Melissa D Kalik4 insp.
Randy L Clarida3 insp.
Doretha M Tonkins2 insp.
Marla A Cassidy2 insp.
Karen M Labounty2 insp.
Jennifer L Custodio1 insp.
Doretha M Wilson1 insp.
Kip J Hanks1 insp.
Cordelia J Brammer1 insp.
Sandra Sejdinovic1 insp.
Kellie L Thommes1 insp.
Jessica L Johnson1 insp.
Gregory S Larson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.80(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 3 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