Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
9 May 2017
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Ademola O Daramola, Don H Bark
9 May 2017
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Ademola O Daramola, Don H Bark
9 May 2017
21 CFR 211.165(a)
Testing and release for distribution
Cited by Ademola O Daramola, Don H Bark
9 May 2017
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by Ademola O Daramola, Don H Bark
Inspected site
NPNovartis Pharma Stein AGStein Ag, Switzerland
Inspection team
AOAdemola O Daramola
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.82(b) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 8 observations
The source PDF and 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