Overview
- 10 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
31 Aug 2016
21 CFR 820.30(g)
Design validation - user needs and intended uses
Cited by Deanna L Lampley
31 Aug 2016
21 CFR 820.30(h)
Design transfer - Lack of or inadequate procedures
Cited by Deanna L Lampley
31 Aug 2016
21 CFR 820.30(g)
Design validation - user needs and intended uses
Cited by Deanna L Lampley
Inspected site
3M3T Medical Systems, LLCLivonia, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.30(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 10 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