Overview
- 8 public-safe observations are available for this inspection.
- 4 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.
30 Nov 2016
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by James A Lane, Sara M Richardson
30 Nov 2016
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by James A Lane, Sara M Richardson
Inspected site
NCNorth Coast Medical IncMorgan Hill, United States
Inspection team
SMSara M Richardson
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 | 2x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 8 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