Overview
- 8 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.
8 Sep 2009
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Jose A Cruz Gonzalez, Parul M Patel
8 Sep 2009
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Jose A Cruz Gonzalez, Parul M Patel
8 Sep 2009
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Jose A Cruz Gonzalez, Parul M Patel
8 Sep 2009
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Jose A Cruz Gonzalez, Parul M Patel
8 Sep 2009
21 CFR 211.101(d)
Component addition checked by 2nd person
Cited by Jose A Cruz Gonzalez, Parul M Patel
Inspected site
FPFareva PauIdron, France
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.101(d) | 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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 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