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FEDERAL REGISTER · NOTICEJune 8, 2023NOTICE — NO LEGAL EFFECT

Analay Rico: Final Debarment Order

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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.

STATUSNOTICE — NO LEGAL EFFECT
EFFECTIVE—
COMMENTS CLOSE—
APPLIES TO · SPEQ TAGDrugDevice
Document type
Notice
Agency
Health and Human Services Department
Published
June 8, 2023
Document number
2023-12249
Docket
FDA-2022-N-2688
ABSTRACT

The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Analay Rico 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. Rico 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. Analay Rico was given notice of the proposed permanent debarment and was given an opportunity to request a hearing to show why she should not be debarred. As of March 3, 2023 (30 days after receipt of the notice), Ms. Rico had not responded. Ms. Rico's failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of her right to a hearing concerning this action.

Abstract as published in the Federal Register.

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