David Winne; Denial of Hearing; Final Debarment Order
What this record is not
Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by David Roy Winne (Winne) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Winne 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 Winne was convicted of multiple felonies under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Winne was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Winne submitted a request for hearing but failed to file with the Agency information and analysis sufficient to create a basis for a hearing.
Abstract as published in the Federal Register.
READ THE FULL DOCUMENT
The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.
View on federalregister.gov →That is what FDA published. A free account files it on your watchlist and sends one weekly email with whatever lands next.
Create a free account