Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
13 Sep 2016
21 CFR 211.167(a)
Sterility/pyrogens - test methods written, followed
Cited by Hala L Selby, Rodney G Raiford
13 Sep 2016
21 CFR 211.180(e)(2)
Items to cover on annual reviews
Cited by Hala L Selby, Rodney G Raiford
13 Sep 2016
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Hala L Selby, Rodney G Raiford
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 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(3) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 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