regulatory
confidence high
sentiment positive
materiality 0.60
LivaNova announces FDA Warning Letter closed for Munich and Arvada facilities
LivaNova PLC
- FDA issued Warning Letter in Dec 2015 over regulatory violations at two facilities.
- Company completed remediation actions to address alleged violations and observations.
- Received FDA communication dated Nov 28, 2022 indicating the Warning Letter is closed.
- No penalty or ongoing compliance obligations detailed in the filing.