Overview
- 2 public-safe observations are available for this inspection.
- 2 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
3 Nov 2015
21 CFR 812.150(b)(10)
No sponsor report in response to a request
Cited by Barbara D Wright, Konsuela Y Glass
3 Nov 2015
21 CFR 812.40
Sponsors' general responsibilities
Cited by Barbara D Wright, Konsuela Y Glass
Inspected site
MSMedtronic Sofamor Danek USA IncMemphis, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 812.150(b)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.40 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 2 observations
The full inspection record, as Atlas holds it, 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