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Third-party inspections now easier

This article was originally published in The Silver Sheet

Executive Summary

Manufacturers no longer need prior approval from FDA to use an accredited third-party auditor instead of agency investigators to conduct quality system inspections of their facilities, according to an FDA guidance released Aug. 25. Firms simply need to notify FDA if they plan to use a third-party inspector. The agency's updated guidelines on its accredited persons [AP] inspection program reflect provisions in the 2007 FDA Amendments Act that make it easier for companies to participate in the historically underused program ("The Silver Sheet" October 2007). The 2007 law also removes a provision that limited a company to two consecutive third-party inspections unless FDA granted a waiver
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