Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
9 Nov 2009
21 CFR 820.75(c)
Process changes - review, evaluation and revalidation
Cited by Ryan J Benedict
9 Nov 2009
21 CFR 820.250(a)
Statistical techniques - Lack of or inadequate procedures
Cited by Ryan J Benedict
Inspected site
SMSignal Medical CorporationMarysville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.184(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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