Overview
- 11 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-05-26.
At a glance
Inspections
11
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 May 2017 – 26 May 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 12 Nov 2014 – 19 Nov 2014 | Medical Devices & Rad Health | Clean | |
| 4 Feb 2014 – 5 Feb 2014 | Medical Devices & Rad Health | Clean | |
| 2 Nov 2012 | Not recorded | Clean | |
| 10 Feb 2012 | Not recorded | Clean | |
| 17 Jun 2011 | Not recorded | Clean | |
| 13 Aug 2009 | Not recorded | Clean | |
| 2 Dec 2008 | Not recorded | 483 | View 483 → |
| 2 Jul 2007 | Not recorded | Clean | |
| 22 Apr 2004 | Not recorded | Clean | |
| 14 Aug 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
26 May 2017
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by Donna L Besone
26 May 2017
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by Donna L Besone
Investigators
FDA investigators tied to this site in the record.
Gene D Arcy3 insp.
Yvette E Guillermo2 insp.
Donna L Besone1 insp.
Natalie J Ayoub1 insp.
Linda Thai1 insp.
Allen F Hall1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 812.43(c)(4)(iii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind NuVasive Inc's 2 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