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Compliance Corner: 9 US FDA Inspection Questions Answered By Agency Officials, Abbott Quality VP

Executive Summary

Are FDA investigators allowed to fish through a messy filing cabinet for documents? And do low-risk class III recalls play into an inspection? FDA investigator Ben Dastoli from the agency's Cincinnati, Ohio, district office, Cincinnati compliance officer Gina Brackett, and Monica Wilkins, divisional VP of QA/RA for device-maker Abbott Laboratories answer those queries and more from manufacturers.

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