08.22.23
David Winne, who served as technical director of AMA Laboratories Inc. when the company falsified lab test results for sunscreen efficacy, must ask federal prosecutors for a recommendation to return to working in the pharmaceutical industry.
The Food and Drug Administration’s Office of the Chief Scientist (OCS) denied Winne’s request for a hearing to argue against the Office of Regulatory Affairs’ proposal made in January to permanently debar him from providing services related to an approved or pending drug product application due to his felony conviction from pleading guilty to conspiracy in 2019 during the FDA and Department of Justice’s investigation of AMA Labs.
The OCS’s notice published in the 18 August Federal Register states that, effectively immediately, it determined Winne is permanently debarred under Secs. 505, 512, or 802 of the Food, Drug & Cosmetic Act [21 USC 355, 360b or 382], or under Public Health Service Act Sec. 351 [42 USC 262].
Winne, along with former AMA employees Mayya Tatsene, Patrycja Wojtowicz and Kaitlyn Gold, pleaded guilty in 2019 in connection with their roles in the scheme. Specifically, they pleaded guilty to wire fraud and conspiracy to commit wire fraud.
Gabriel Letizia Jr. Sentenced to 60 Months in Prison for Falsifying Sunscreen Test Results
The Food and Drug Administration’s Office of the Chief Scientist (OCS) denied Winne’s request for a hearing to argue against the Office of Regulatory Affairs’ proposal made in January to permanently debar him from providing services related to an approved or pending drug product application due to his felony conviction from pleading guilty to conspiracy in 2019 during the FDA and Department of Justice’s investigation of AMA Labs.
The OCS’s notice published in the 18 August Federal Register states that, effectively immediately, it determined Winne is permanently debarred under Secs. 505, 512, or 802 of the Food, Drug & Cosmetic Act [21 USC 355, 360b or 382], or under Public Health Service Act Sec. 351 [42 USC 262].
Winne, along with former AMA employees Mayya Tatsene, Patrycja Wojtowicz and Kaitlyn Gold, pleaded guilty in 2019 in connection with their roles in the scheme. Specifically, they pleaded guilty to wire fraud and conspiracy to commit wire fraud.
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Gabriel Letizia Jr. Sentenced to 60 Months in Prison for Falsifying Sunscreen Test Results