Sandoz GmbH
FDA inspection history in Kundl, Austria, 2018 to 2021
- 2
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Kundl, Austria.
- 2021One Form 483, at Kundl, Austria.
- 2021The longest 483 on file: 5 observations over 2 pages at Kundl, Austria.
Cited most
Across all Sandoz observations on file
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 207.17Who must register?1
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.160General requirements1
- 21 CFR 211.192Production record review1
The complete Sandoz file.
All 2 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
Kundl, Austria
Two Form 483s · 2018 to 2021 · 9 observations
Latest: Form 483, Dec 17, 2021 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-12-17 | 483 Form 483 | Kundl, Austria | 5 | $99 |
| 2018-09-18 | 483 Form 483 | Kundl, Austria | 4 | $99 |
Investigators on these documents
Margaret M. Annes (1)Susan T. Hadman (1)Wayne Seifert (1)Xianghong Jing (1)
FEI number 3002806523 · most recent document Dec 17, 2021
About Sandoz GmbH
How many FDA Form 483s has Sandoz GmbH received?
FDA Intel has 2 Form 483s on file for Sandoz GmbH; the most recent is dated Dec 17, 2021.
When was Sandoz GmbH last inspected by FDA?
The most recent FDA inspection document on file for Sandoz GmbH is a Form 483 dated Dec 17, 2021, for the site in Kundl, Austria.
What did FDA cite at Sandoz GmbH?
The regulations cited most in the observations on file for Sandoz GmbH are 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 207.17 (Who must register?), 1 time; 21 CFR 211.100 (Written procedures; deviations), 1 time.