Bavarian Nordic Berna GmbH
Form 483 issued September 22, 2017 · Thörishaus, Switzerland
- Inspection
- Sep 15 – Sep 22, 2017
- Investigators
- Burnell M. Henry· Jacqueline Diaz-Albertini
- Observations
- 3
- Pages
- 3
- FEI number
- 3011237656
In short: On September 22, 2017, FDA issued a Form 483 with 3 observations to Bavarian Nordic Berna GmbH in Thörishaus, Bern (FEI 3011237656) after an inspection that ran Sep 15 – Sep 22, 2017. The investigators were Burnell M. Henry and Jacqueline Diaz-Albertini. Most observations concern biologics CGMP and quality system; the most-cited regulation is 21 CFR 601.12 (changes to an approved application).
At a glance
2 of 3 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 601.12 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Validated lyophilization process parameters were modified and not revalidated prior to product release. Process validation report…
- 02
There is a failure to file appropriate…
- 03
The following deficiencies regarding procedures and practices for the evaluation of…
This inspection in context
Burnell M. Henry
22 documents · 2012–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in North Carolina.
The firmBavarian Nordic Berna GmbH history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 601.12
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bavarian Nordic Berna GmbH?
FDA listed 3 observations on this Form 483, mostly about biologics CGMP and quality system. The most-cited regulation is 21 CFR 601.12 (changes to an approved application). The opening words of each observation are shown on this page.
Who inspected Bavarian Nordic Berna GmbH?
Burnell M. Henry and Jacqueline Diaz-Albertini are named on this Form 483, for the inspection of Sep 15 – Sep 22, 2017. Each investigator has a profile showing what they cite most.
When was Bavarian Nordic Berna GmbH inspected by FDA?
The inspection ran Sep 15 – Sep 22, 2017, and the Form 483 is dated September 22, 2017.
How do I get the full Form 483 for Bavarian Nordic Berna GmbH?
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