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QUOTED. May 16, 2018. Ricki Chase.

Executive Summary

US FDA has set up an email inbox to accept inquiries from device-makers about facility inspections under its year-old "program alignment" audit scheme. See what former FDA investigations branch director (now consultant) Ricki Chase said about it here.

"Firms are always afraid to ask questions, because if the question indicates that maybe there's an issue, they're worried that they're going to be inspected. But that's just not how it works. The agency is trying to be more transparent and more user-friendly, and part of being more user-friendly is to establish this general question inbox [ORAHQDeviceInspectionPOC@fda.hhs.gov] where you can send a question, and somebody will get back to you with a reference or a resource. Or sometimes they'll say, 'Give me a call and we can discuss it.'" –Ricki Chase, compliance practice director, Lachman Consultant Services

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