Overview
- 18 public-safe observations are available for this inspection.
- 6 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.
20 Sep 2018
21 CFR 820.120(b)
DHR documentation of label release {see also 820.184}
Cited by Gamal A Norton
20 Sep 2018
21 CFR 820.120(b)
DHR documentation of label release {see also 820.184}
Cited by Gamal A Norton
Inspected site
EGEizo GmbHRulzheim, Germany
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.120(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.198(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.200(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 3x |
Full 483 report
Get the verbatim text of all 18 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