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Notice2021-25589

Maytee Lledo: Final Debarment Order

Primary source

Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.

Published
November 23, 2021

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Maytee Lledo 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 Ms. Lledo was convicted of a felony under Federal law for conduct that relates to the development or approval, including the process for development or approval, of any drug product under the FD&C Act. Ms. Lledo was given notice of the proposed permanent debarment and an opportunity to request a hearing to show why she should not be debarred within the timeframe prescribed by regulation. Ms. Lledo has not responded to the notice. Ms. Lledo's failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of her right to a hearing concerning this action.

Indexed from Federal Register on November 23, 2021.

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.