Module 16 2022

02/09/2022

Penalties

Civil penalties for administrative offences

● “Significant” or “knowing” violations or a risk to public health

● FDA can act administratively to fine – US$15,000 for each violation – Up to US$1,000,000 maximum for a single “proceeding” – Consent decrees

● Against

– company – individuals

The Organisation for Professionals in Regulatory Affairs

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Penalties (cont.) Criminal sanctions ● Strict criminal liability ● Vicarious liability ● Misdemeanor or felony

– Up to a $1,000 fine and one year imprisonment for the first offence, if unintentional – Up to $10,000 and three years imprisonment for subsequent offences, or for intentional offences ● U.S. and non-U.S. residents

● C.R. Bard

● Debarment

The Organisation for Professionals in Regulatory Affairs

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