Bavarian Nordic Berna GmbH
Form 483 issued December 14, 2018 · Thörishaus, Switzerland
- Inspection
- Dec 6 – Dec 14, 2018
- Investigators
- Mihaly S. Ligmond· Travis S. Bradley
- Observations
- 12
- Pages
- 5
- FEI number
- 3011237656
In short: On December 14, 2018, FDA issued a Form 483 with 12 observations to Bavarian Nordic Berna GmbH in Thörishaus, Bern (FEI 3011237656) after an inspection that ran Dec 6 – Dec 14, 2018. The investigators were Mihaly S. Ligmond and Travis S. Bradley. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 4 systems, led by laboratory controls.
Most cited: 21 CFR 211.192 (2×) · 211.56 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
EOYGY drug product required to be tree of objectionable microorganisms is not tested…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not (BY (4)…
- 03
There are no written procedures for the receipt, evaluation, reporting of post-marketing…
- 04
Biological product deviations were not reported within the…
This inspection in context
Mihaly S. Ligmond
20 documents · 2006–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ireland.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bavarian Nordic Berna GmbH?
FDA listed 12 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Bavarian Nordic Berna GmbH?
Mihaly S. Ligmond and Travis S. Bradley are named on this Form 483, for the inspection of Dec 6 – Dec 14, 2018. Each investigator has a profile showing what they cite most.
When was Bavarian Nordic Berna GmbH inspected by FDA?
The inspection ran Dec 6 – Dec 14, 2018, and the Form 483 is dated December 14, 2018.
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.