Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
17 Jul 2015
21 CFR 211.166(a)(4)
Testing in same container - closure system
Cited by Lucila B Nwatu, Darren S Brown, Robert D Tollefsen
17 Jul 2015
21 CFR 211.170(b)
Reserve samples identified, representative, stored
Cited by Lucila B Nwatu, Darren S Brown, Robert D Tollefsen
17 Jul 2015
21 CFR 211.188(b)(8)
Labeling control records including specimens or copies
Cited by Lucila B Nwatu, Darren S Brown, Robert D Tollefsen
17 Jul 2015
21 CFR 211.160(b)(4)
Establishment of calibration procedures
Cited by Lucila B Nwatu, Darren S Brown, Robert D Tollefsen
17 Jul 2015
21 CFR 211.166(a)(2)
Stability sample storage conditions described
Cited by Lucila B Nwatu, Darren S Brown, Robert D Tollefsen
Inspected site
NPNovartis Pharmaceuticals CorporationSan Carlos, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(8) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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