⚖️FDA Denies Hearing and Issues Permanent Debarment for Garmendia
The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by Bernardo Garmendia, also known as Bernardo Germendia, (Garmendia) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Garmendia 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 Garmendia 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. FDA provided notice to Garmendia of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Garmendia submitted a request for hearing but failed to file with the Agency information and analyses sufficient to create a basis for a hearing.
Learn More🚫FDA Issues 10-Year Debarment Order Against Harpreet Singh
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Harpreet Singh for a period of 10 years from importing or offering for import any drug into the United States. FDA bases this order on a finding Mr. Singh was convicted of multiple felony offenses, which serve as the basis for this debarment, that are conspiracy to possess with intent to distribute cathinone, tapentadol, tramadol, and carisoprodol; one felony count under Federal law for fraudulent importation and transportation of goods; one felony count under Federal law for conspiracy to launder money; and one felony count under Federal law for conspiracy to obstruct justice. The factual basis supporting Mr. Singh's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Singh was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of November 20, 2024 (30 days after receipt of the notice), Mr. Singh had not responded. Mr. Singh's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Learn More⚖️FDA Debarment Order Against Jonathan Corbett Cosie
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jonathan Corbett Cosie for a period of 10 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Cosie was convicted of two felony counts under Federal law for introducing misbranded drugs into interstate commerce with the intent to defraud and mislead. The factual basis supporting Mr. Cosie's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Cosie was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of January 6, 2025 (30 days after receipt of the notice), Mr. Cosie had not responded. Mr. Cosie's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Learn More⚖️Implications of John Kosolcharoen's FDA Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring John Warrington Kosolcharoen from providing services in any capacity to a person that has an approved or pending drug product application including, but not limited to, a biologics license application (BLA). FDA bases this order on a finding that Mr. Kosolcharoen was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Kosolcharoen was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of December 26, 2024 (30 days after receipt of the notice), Mr. Kosolcharoen has not responded. Mr. Kosolcharoen's failure to respond and request a hearing constitutes a waiver of Mr. Kosolcharoen's right to a hearing concerning this matter.
Learn More🚫FDA Debars Alnashir Punjani for 5 Years
The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Alnashir Alibhai Punjani for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Punjani was convicted of one felony count under Federal law for conspiracy to deliver and introduce unapproved drugs. The factual basis supporting Mr. Punjani's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Punjani was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of November 10, 2024 (30 days after receipt of the notice), Mr. Punjani had not responded. Mr. Punjani's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Learn More🚫FDA Denies Hearing; Jiao Debarred for Five Years from Drug Imports
The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by Yong Sheng Jiao, also known as Yongsheng Jiao and Wilson Jiao (Jiao), and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jiao for 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Jiao was convicted of a felony under Federal law for conduct relating to the importation into the United States of any drug or controlled substance under the FD&C Act. In determining the appropriateness and period of Jiao's debarment, FDA considered the relevant factors listed in the FD&C Act. Jiao submitted a request for hearing but failed to file with the Agency information and analyses sufficient to create a basis for a hearing.
Learn More❌FDA Withdraws Notice on Yong Sheng Jiao's Debarment Order
The Food and Drug Administration (FDA) is issuing this notice to withdraw the December 5, 2024, Federal Register notice entitled "Yong Sheng Jiao; Denial of Hearing; Final Debarment Order" because the document provided the incorrect bases for debarment and omitted edited language. A corrected notice document is published elsewhere in this Federal Register.
Learn More⚖️FAR Amendments Enhancing Compliance for Federal Contractors
DoD, GSA, and NASA are issuing a final rule amending the Federal Acquisition Regulation (FAR) to improve consistency between the procurement and nonprocurement procedures on suspension and debarment, based on the recommendations of the Interagency Suspension and Debarment Committee.
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