Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
6 Aug 2009
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by Susan M Matthias, Melissa I Michurski
6 Aug 2009
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Susan M Matthias, Melissa I Michurski
6 Aug 2009
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Susan M Matthias, Melissa I Michurski
6 Aug 2009
21 CFR 820.40
Lack of procedures, or not maintained
Cited by Susan M Matthias, Melissa I Michurski
Inspected site
MIMedtronic, Inc.Mounds View, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 observations
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