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The government awards contracts to companies with histories of misconduct such as contract fraud and environmental, ethics, and labor violations. In the absence of a centralized federal database listing instances of misconduct, the Project On Government Oversight (POGO) is providing such data. We believe that it will lead to improved contracting decisions and public access to information about how the government spends hundreds of billions of taxpayer money each year on goods and services. Report an instance of misconduct »

AmerisourceBergen

Failure to Request FDA Approval

Date: 10/11/2002 (Date of Violation Notification)

Misconduct Type: Health

Enforcement Agency: Health and Human Servs.

Contracting Party: None

Court Type: Administrative

Amount: $0

Disposition: Administrative Agreement

Synopsis: On October 11, 2002 the FDA submitted a letter to Amerisource Health Services Corporation, a subsidiary of AmerisourceBergen, in reference to the firm’s marketing of Humibid LA Tablets. The FDA had recently approved a similar drug; however, Amerisource had not received approval for Humibid. Marketing this new drug without FDA approval violated the Federal Food, Drug, and Cosmetic Act and required Amerisource to bring its marketing efforts into compliance with the act.