Bavarian Nordic Berna GmbH
Form 483 issued September 11, 2015 · Thörishaus, Switzerland
- Inspection
- Sep 3 – Sep 11, 2015
- Investigators
- Debra M. Emerson· Gene Arey
- Observations
- 8
- Pages
- 3
- FEI number
- 3011237656
In short: On September 11, 2015, FDA issued a Form 483 with 8 observations to Bavarian Nordic Berna GmbH in Thörishaus, Bern (FEI 3011237656) after an inspection that ran Sep 3 – Sep 11, 2015. The investigators were Debra M. Emerson and Gene Arey.
What FDA observed
Preview: the opening words of each observation- 01
Pursuant to Section 704(b) of the Federal Food, Drug…
- 02
To assist firms inspected in complying with the Acts and regulations…
This inspection in context
Debra M. Emerson
27 documents · 2008–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Massachusetts.
The firmBavarian Nordic Berna GmbH history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
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Questions about this 483
What did FDA find at Bavarian Nordic Berna GmbH?
FDA listed 8 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Bavarian Nordic Berna GmbH?
Debra M. Emerson and Gene Arey are named on this Form 483, for the inspection of Sep 3 – Sep 11, 2015. Each investigator has a profile showing what they cite most.
When was Bavarian Nordic Berna GmbH inspected by FDA?
The inspection ran Sep 3 – Sep 11, 2015, and the Form 483 is dated September 11, 2015.
How do I get the full Form 483 for Bavarian Nordic Berna GmbH?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.