Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
5 Mar 2015
21 CFR 211.100(a)
Changes to Procedures Not Reviewed, Approved
Cited by Patric C Klotzbuecher, Junho Pak
5 Mar 2015
21 CFR 211.186(b)(9)
Manufacturing Instructions and Specifications
Cited by Patric C Klotzbuecher, Junho Pak
5 Mar 2015
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Patric C Klotzbuecher, Junho Pak
Inspected site
NSNerPharMa S.r.l.Nerviano, Italy
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 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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