Overview
- 3 public-safe observations are available for this inspection.
- 2 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.
2 Jul 2009
21 CFR 211.80(a)
Written Procedures Not Followed
Cited by Torrance J Slayton, Tina M Pawlowski
2 Jul 2009
21 CFR 211.122(a)
Sampling/testing of labeling/packaging materials
Cited by Torrance J Slayton, Tina M Pawlowski
Inspected site
FHF. Hoffmann-La Roche AGKaiseraugst, Switzerland
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 3 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