Federal law does not require the FDA to inspect a device plant such as AM2PAT before production starts, said Jeffrey Gibbs, an FDA expert with the Washington law firm of Hyman, Phelps & McNamara, who advises health-care companies.
Although they are supposed to be inspected every two years, plants such as AM2PAT have instead gotten site visits about once every five years, according to a report from the Government Accountability Office. Between 2002 and 2007, FDA inspectors visited only about one-quarter of the 5,616 registered plants per year, the GAO report states.
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