Overview
- 10 public-safe observations are available for this inspection.
- 9 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.
28 Apr 2010
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Jose A Cruz Gonzalez, Javier O Vega
28 Apr 2010
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Jose A Cruz Gonzalez, Javier O Vega
28 Apr 2010
21 CFR 211.67(c)
Cleaning/maintenance records not kept
Cited by Jose A Cruz Gonzalez, Javier O Vega
28 Apr 2010
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Jose A Cruz Gonzalez, Javier O Vega
28 Apr 2010
21 CFR 211.68(a)
Written calibration / inspection records not kept
Cited by Jose A Cruz Gonzalez, Javier O Vega
Inspected site
VPVet Pharma Friesoythe GmbHFriesoythe, Germany
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
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