Overview
- 9 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2022-10-11.
At a glance
Inspections
9
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Oct 2022 | Biologics | Clean | |
| 20 Aug 2018 – 23 Aug 2018 | Biologics | Clean | |
| 3 Mar 2016 – 9 Mar 2016 | Biologics | Clean | |
| 30 Oct 2013 – 4 Nov 2013 | Biologics | Clean | |
| 13 Feb 2012 | Not recorded | 483 | View 483 → |
| 2 Dec 2010 | Not recorded | Clean | |
| 6 Nov 2009 | Not recorded | Clean | |
| 8 Sep 2008 | Not recorded | Clean | |
| 25 Jan 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Feb 2012
21 CFR 640.3(c)(2)
History of viral hepatitis - close contact
Cited by Lakecha N Lewis, Timothy P Lafave
Investigators
FDA investigators tied to this site in the record.
Timothy P Lafave4 insp.
Laurissa S Flowers1 insp.
Dylan R Jock1 insp.
Sarah M Forney1 insp.
Yvonne C Wilkes1 insp.
Lakecha N Lewis1 insp.
Sonya L Karsik1 insp.
Steven E Porter1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 640.3(c)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 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