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US third party inspection plan takes shape as nominees are listed

This article was originally published in Clinica

Executive Summary

The FDA has released the names of the15 companies that will be authorised to perform quality systems inspections in lieu of the FDA in the first year of the agency's third party inspection programme. The companies selected to fill this year's 15 available slots were chosen from a list of 18 that met the agency's minimum criteria for acceptance out of 23 total applicants. To qualify, companies could have no ownership stake in any FDA-regulated company and their staff had to meet the same academic qualifications as comparable FDA officials (see Clinica No 1080, p 1).

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