⚖️FDA Denies Hearing and Issues Permanent Debarment for Garmendia
Bernardo Garmendia; Denial of Hearing; Final Debarment Order
Summary
The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by Bernardo Garmendia, also known as Bernardo Germendia, (Garmendia) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Garmendia from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Garmendia was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product under the FD&C Act. FDA provided notice to Garmendia of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Garmendia submitted a request for hearing but failed to file with the Agency information and analyses sufficient to create a basis for a hearing.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The regulation permanently debars Bernardo Garmendia from providing services related to drug product applications due to felony conviction. Businesses must ensure compliance and avoid hiring individuals under debarment to prevent civil penalties.