Bavarian Nordic Berna GmbH
FDA inspection history in Thörishaus, Switzerland, 2015 to 2019
- 4
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2017: one Form 483; 2018: one Form 483; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–19Four Form 483s, at Thörishaus, Switzerland.
- 2018The longest 483 on file: 12 observations over 5 pages at Thörishaus, Switzerland.
Cited most
Across all Bavarian Nordic Berna observations on file
- 21 CFR 211.160General requirements2
- 21 CFR 211.192Production record review2
- 21 CFR 211.56Sanitation2
- 21 CFR 601.12Changes to an approved application2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
The complete Bavarian Nordic Berna 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
Thörishaus, Switzerland
Four Form 483s · 2015 to 2019 · 25 observations
Latest: Form 483, Mar 15, 2019 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-03-15 | 483 Form 483 | Thörishaus, Switzerland | 2 | $99 |
| 2018-12-14 | 483 Form 483 | Thörishaus, Switzerland | 12 | $99 |
| 2017-09-22 | 483 Form 483 | Thörishaus, Switzerland | 3 | $99 |
| 2015-09-11 | 483 Form 483 | Thörishaus, Switzerland | 8 | $99 |
Investigators on these documents
Burnell M. Henry (1)Debra M. Emerson (1)Gene Arey (1)Gregory Price (1)Jacqueline Diaz-Albertini (1)Mihaly S. Ligmond (1)Richard Heath Coats (1)Travis S. Bradley (1)
FEI number 3011237656 · most recent document Mar 15, 2019
About Bavarian Nordic Berna GmbH
How many FDA Form 483s has Bavarian Nordic Berna GmbH received?
FDA Intel has 4 Form 483s on file for Bavarian Nordic Berna GmbH; the most recent is dated Mar 15, 2019.
When was Bavarian Nordic Berna GmbH last inspected by FDA?
The most recent FDA inspection document on file for Bavarian Nordic Berna GmbH is a Form 483 dated Mar 15, 2019, for the site in Thörishaus, Switzerland.
What did FDA cite at Bavarian Nordic Berna GmbH?
The regulations cited most in the observations on file for Bavarian Nordic Berna GmbH are 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.56 (Sanitation), 2 times.