Bavarian Nordic Berna GmbH
Form 483 issued March 15, 2019 · Thörishaus, Switzerland
- Inspection
- Mar 11 – Mar 15, 2019
- Investigators
- Gregory Price· Richard Heath Coats
- Observations
- 2
- Pages
- 2
- FEI number
- 3011237656
In short: On March 15, 2019, FDA issued a Form 483 with 2 observations to Bavarian Nordic Berna GmbH in Thörishaus, Bern (FEI 3011237656) after an inspection that ran Mar 11 – Mar 15, 2019. The investigators were Gregory Price and Richard Heath Coats.
What FDA observed
Preview: the opening words of each observation- 01
Yarug product shipping validation from the drug product manufacturer to…
- 02
Validation of Drug Supply Chain Security for the Building PS Packaging Line has not been completed…
This inspection in context
Gregory Price
3 documents · 2019–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Florida.
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 2 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Bavarian Nordic Berna GmbH?
Gregory Price and Richard Heath Coats are named on this Form 483, for the inspection of Mar 11 – Mar 15, 2019. Each investigator has a profile showing what they cite most.
When was Bavarian Nordic Berna GmbH inspected by FDA?
The inspection ran Mar 11 – Mar 15, 2019, and the Form 483 is dated March 15, 2019.
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.