Novartis Pharma Stein AG
FDA inspection history in Stein, Switzerland, 2017 to 2022
- 4
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2018: two Form 483s; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–18Three Form 483s, at Stein, Switzerland.
- 2017The longest 483 on file: 8 observations over 9 pages at Stein, Switzerland.
- 2022One Form 483, at Stein, Switzerland.
Cited most
Across all Novartis Pharma Stein AG observations on file
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.192Production record review2
- 21 CFR 211.58Maintenance2
- 21 CFR 211.67Equipment cleaning and maintenance2
The complete Novartis Pharma Stein AG file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Stein, Switzerland
Four Form 483s · 2017 to 2022 · 19 observations
Latest: Form 483, Dec 6, 2022 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-12-06 | 483 Form 483 | Stein, Switzerland | 5 | $99 |
| 2018-12-04 | 483 Form 483 | Stein, Switzerland | 3 | $99 |
| 2018-09-21 | 483 Form 483 | Stein, Switzerland | 3 | $99 |
| 2017-05-09 | 483 Form 483 | Stein, Switzerland | 8 | $99 |
Investigators on these documents
FEI number 3002653483 · most recent document Dec 6, 2022
About Novartis Pharma Stein AG
How many FDA Form 483s has Novartis Pharma Stein AG received?
FDA Intel has 4 Form 483s on file for Novartis Pharma Stein AG; the most recent is dated Dec 6, 2022.
When was Novartis Pharma Stein AG last inspected by FDA?
The most recent FDA inspection document on file for Novartis Pharma Stein AG is a Form 483 dated Dec 6, 2022, for the site in Stein, Switzerland.
What did FDA cite at Novartis Pharma Stein AG?
The regulations cited most in the observations on file for Novartis Pharma Stein AG are 21 CFR 211.100 (Written procedures; deviations), 3 times; 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.192 (Production record review), 2 times.