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debarment fda
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206 documents for debarment fda
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The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act permanently debarring Scott S. Reuben, M.D. 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 Dr. Reuben was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the Federal Food, Drug, and Cosmetic Act. Dr. Reuben was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Reuben failed to respond. Dr. Reuben's failure to respond constitutes a waiver of his right to a hearing concerning this action.
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The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Gayle Rothenberg, MD, from providing services in any capacity to a person that has an approved or pending drug product application. We base this order on a finding that Dr. Rothenberg was convicted of felonies under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Dr. Rothenberg was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Rothenberg failed to respond. Dr. Rothenberg's failure to respond constitutes a waiver of her right to a hearing concerning this action.
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The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Anneri Izurieta for a period of 30 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Ms. Izurieta was convicted of six felony counts under Federal law for conduct relating to the importation into the United States of an article of food. Ms. Izurieta was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of November 4, 2011 (30 days after receipt of the notice), Ms. Izurieta had not responded. Ms. Izurieta's failure to respond constitutes a waiver of her right to a hearing concerning thi...
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The U.S. Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Yuri Izurieta for a period of 20 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Izurieta was convicted of six felony counts under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Izurieta was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of November 10, 2011 (30 days after receipt of the notice), Mr. Izurieta had not responded. Mr. Izurieta's failure to respond constitutes a waiver of his right to a hearing concerning thi...
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The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Jyotin Parikh for 5 years 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 Mr. Parikh was convicted of one count of conspiracy to commit an offense against the United States for conduct relating to the development and approval, including the process for development and approval, of a drug product and to the regulation of drug products under the FD&C Act. In addition, the type of conduct underlying the conviction undermined the process for the regulation of drugs. Mr. Parikh was given notice of the proposed debarment and an opportunity to request a hear...
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The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Shashikant Shah for 5 years 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 Mr. Shah was convicted of one count of conspiracy to commit an offense against the United States for conduct relating to the development and approval, including the process for development and approval, of a drug product and to the regulation of drug products under the FD&C Act. In addition, the type of conduct underlying the conviction undermined the process for the regulation of drugs. Mr. Shah was given notice of the proposed debarment and an opportunity to request a hearin...
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The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Ashish Macwan for 5 years 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 Mr. Macwan was convicted of one count of conspiracy to commit an offense against the United States for conduct relating to the development and approval, including the process for development and approval, of a drug product and to the regulation of drug products under the FD&C Act. In addition, the type of conduct underlying the conviction undermined the process for the regulation of drugs. Mr. Macwan was given notice of the proposed debarment and an opportunity to request a hear...
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The U.S. Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring David H.M. Phelps for a period of 20 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Phelps was convicted, as defined in section 306(l)(1)(B) of the FD&C Act (21 U.S.C. 335a(l)(1)(B)), of 10 felony counts under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Phelps was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of March 31, 2012 (30 days after receipt of the notice), Mr. Phelps had not responded. Mr. Phelps's failu...
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The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Jose Concepcion for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on findings that Mr. Concepcion was convicted of conspiracy to commit an offense against the United States, that the conduct that served as the basis for the felony conspiracy conviction relates to the development or approval, including the process for development or approval, of any drug product and relates to the regulation of drug products under the FD&C Act, and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. Mr. Concepcion was given no...
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The U.S. Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Karen L. Blyth for a period of 20 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Ms. Blyth was convicted, as defined in section 306(l)(1)(B) of the FD&C Act (21 U.S.C. 335a(l)(1)(B)), of 10 felony counts under Federal law for conduct relating to the importation into the United States of an article of food. Ms. Blyth was given notice of the proposed debarment and an opportunity to request a hearing within the time frame prescribed by regulation. As of March 23, 2012 (30 days after receipt of the notice), Ms. Blyth had not responded. Ms. Blyth's failure to ...
