Federal Register #FDA-2026-N-4019

FDA Final Debarment Order Prohibiting Drug Imports by Convicted Individual

This enforcement action from the Food and Drug Administration (FDA), under the Department of Health and Human Services, addresses the prohibition of drug imports by an individual convicted of trafficking counterfeit pharmaceuticals. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - Merck Sharp & Dohme LLC (OEM for Keytruda) - Products/Services Mentioned: - Keytruda (counterfeit pharmaceutical product) - Unique or Notable Requirements: - Sanjay Kumar is prohibited from importing or offering for import any drug into the United States for five years - Action is based on conviction for conspiracy to traffic in counterfeit goods - Counterfeit drugs lacked the active ingredient required for medical treatment - No procurement or solicitation of products/services; strictly an enforcement action - Additional Details: - Notice and opportunity for hearing were provided, but the individual failed to respond, waiving the right to a hearing

Description

The Food and Drug Administration (FDA) is issuing a final debarment order against Sanjay Kumar for a period of 5 years, prohibiting him from importing or offering for import any drug into the United States. This action is based on Mr. Kumar's conviction for conspiracy to traffic in counterfeit goods, specifically involving counterfeit pharmaceutical products such as Keytruda. The order details the illegal importation and sale of counterfeit drugs that lacked the active ingredient necessary for medical treatment. Mr. Kumar was given notice and an opportunity for a hearing but failed to respond, resulting in a waiver of his right to a hearing.

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