Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-09-28.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 26 Sep 2022 – 28 Sep 2022 | Biologics | Clean | |
| 30 Sep 2015 – 2 Oct 2015 | Biologics | Clean | |
| 14 Oct 2014 – 31 Oct 2014 | Biologics | 483 | View 483 → |
| 4 Sep 2013 – 6 Sep 2013 | Biologics | 483 | On file |
| 26 Oct 2012 | Not recorded | 483 | On file |
| 29 Oct 2010 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
31 Oct 2014
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Erika M Wilkerson, Gayle S Lawson, Megan M Lauff
31 Oct 2014
21 CFR 606.100(c)
Thorough investigations
Cited by Erika M Wilkerson, Gayle S Lawson, Megan M Lauff
31 Oct 2014
21 CFR 630.40(b)(3)
Results of testing
Cited by Erika M Wilkerson, Gayle S Lawson, Megan M Lauff
Investigators
FDA investigators tied to this site in the record.
Linda S Mattingly2 insp.
Cara M Minelli1 insp.
Kish Bolden1 insp.
James P Mcevoy1 insp.
Erika M Wilkerson1 insp.
Gayle S Lawson1 insp.
Megan M Lauff1 insp.
Laurie A Haxel1 insp.
Linda M Hoover1 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 606.100(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.40(b)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 4 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