Inside US Trade: FDA Pressed On Budget Needed To Expand Foreign Drug Inspections
Inside US Trade,
April 25, 2008
...[Oversight and Investigation] subcommittee member Rep. Michael Burgess (R-TX) emphasized their view that FDA should be compelled to do a pre-inspection prior to approving a new active pharmaceutical ingredient supplier abroad. This is currently not mandated in law, but represents a long-standing FDA policy. FDA has admitted it did not inspect the Chinese producer of Heparin ingredients linked to its contamination...
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