Overview
- 1 public-safe observation is available for this inspection.
- 1 structured CFR citation is represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
2 Dec 2008
21 CFR 812.43(c)(4)(iii)
No informed consent statement in investigator agreement
Cited by Yvette E Guillermo
Inspected site
NINuVasive IncSan Diego, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 812.43(c)(4)(iii) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
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Every observation in full, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere