Resources for Food and Drug Administration (FDA)
FDA failure on foreign inspections frightening
www.outsourcing-pharma.com A US government audit has confirmed the Food and Drug Administration's (FDA's) continual lack of inspection of foreign drug manufacturing plants.
The revelation is frightening considering that 75-80 per cent of all active pharmaceutical ingredients (APIs) used by US drug manufacturers are now imported, mainly from India and China, along with 40 per cent of finished dosage forms from various global locations.
The worrying situation has long been highlighted by the US and EU industry trade bodies - the Synthetic Organic Chemical Manufacturers Association (SOCMA) and the European Fine Chemicals Group (EFCG) - who have been campaigning for regulators to increase their inspections of foreign facilities.
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