Sandoz GmbH
FDA inspection history in Langkampfen, Austria, 2016 to 2023
- 5
- Form 483s
Every document, by year
- Form 483
2016: two Form 483s; 2017: one Form 483; 2018: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–18Four Form 483s, at Langkampfen, Austria.
- 2018The longest 483 on file: 4 observations over 1 pages at Langkampfen, Austria.
- 2023One Form 483, at Langkampfen, Austria.
Cited most
Across all Sandoz observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.111Time limitations on production2
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.192Production record review1
- 21 CFR 211.42(c)(10)(iv)Design and construction features1
The complete Sandoz file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Langkampfen, Austria
Five Form 483s · 2016 to 2023 · 12 observations
Latest: Form 483, Jan 12, 2023 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-01-12 | 483 Form 483 | Langkampfen, Austria | 2 | $99 |
| 2018-02-20 | 483 Form 483 | Langkampfen, Austria | 4 | $99 |
| 2017-10-13 | 483 Form 483 | Langkampfen, Austria | 1 | $99 |
| 2016-07-05 | 483 Form 483 | Langkampfen, Austria | 3 | $99 |
| 2016-03-11 | 483 Form 483 | Langkampfen, Austria | 2 | $99 |
Investigators on these documents
Zhong Li (2)Deborah Schmiel (1)Jose Lopez-Barragan (1)Laura Fontan (1)Marjorie A. Shapiro (1)Maryam Tabatabaie (1)Anjali Shukla (1)Peter Adams (1)Reyes Candau-Chacon (1)Scott R. Nichols (1)William Hallett (1)Michael R. Shanks (1)
FEI number 3004828473 · most recent document Jan 12, 2023
About Sandoz GmbH
How many FDA Form 483s has Sandoz GmbH received?
FDA Intel has 5 Form 483s on file for Sandoz GmbH; the most recent is dated Jan 12, 2023.
When was Sandoz GmbH last inspected by FDA?
The most recent FDA inspection document on file for Sandoz GmbH is a Form 483 dated Jan 12, 2023, for the site in Langkampfen, Austria.
What did FDA cite at Sandoz GmbH?
The regulations cited most in the observations on file for Sandoz GmbH are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.111 (Time limitations on production), 2 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times.