Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
7 Apr 2009
21 CFR 820.40
Lack of procedures, or not maintained
Cited by Meredith L Sheridan, Amy M Cramer
7 Apr 2009
21 CFR 820.72(a)
Equipment control activity documentation
Cited by Meredith L Sheridan, Amy M Cramer
7 Apr 2009
21 CFR 820.120(d)
Records, DHR {see also 820.184(e)}
Cited by Meredith L Sheridan, Amy M Cramer
7 Apr 2009
21 CFR 820.181(b)
DMR production process specifications
Cited by Meredith L Sheridan, Amy M Cramer
Inspected site
NCNano-Ditech CorporationCranbury, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.120(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | 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