FDA to outsource manufacturing inspections

The US Food and Drug Administration (FDA) is pushing for Congress to approve the use of more third-party inspectors as the regulatory body attempts to police a complex global supply chain.

By outsourcing some of the inspections the FDA believes that it can more efficiently use the $275m extra funding which it is hoping to receive.

The Government Accountability Office (GAO) has stated that foreign plants are inspected every 13 years as opposed to 2.7 years for facilities in the US, a situation the FDA is hoping to resolve.

However, the outsourcing plan has already drawn criticism, primarily targeted at the perceived failure of a similar scheme for inspections of device manufacturers.

The outsourcing idea was mooted last autumn, when the Bush administration proposed a plan for non-FDA inspections of prescription pharmaceuticals. This would be done on a voluntary basis for products that are not considered to pose too great a risk, with manufacturers paying for the inspections.


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