The Heparin Disaster: New International Pilot Program to Facilitate Overseas Inspections
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The Heparin Disaster

A running commentary on the contaminated heparin disaster caused by Baxter Healthcare's distribution of contaminated heparin from Scientific Protein Lab's API, and the deaths and injuries resulting therefrom.

Tuesday, July 15, 2008  

New International Pilot Program to Facilitate Overseas Inspections

Last week, the U.S. Department of Health and Human Services (HHS) announced a new program in conjunction with the U.S. Food and Drug Administration (“FDA”) to enhance the safety of medical drugs and food exported to the United States. (07/09/08 HHS Press Release.)

Specifically, the program is a pilot project with the European Union and Australian authorities “to jointly plan, allocate for and conduct inspections of drug-manufacturing facilities.” (07/09/08 HHS Press Release.) The program will initially focus on makers of active pharmaceutical ingredients, but will expand to other types of manufacturing facilities if successful.

Additional information about this import safety initiative, as well as other import safety news, reports and blogs are available at the HHS’ import safety website: http://www.importsafety.gov/.

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