Prospects for FDA use of third-party certification.

R Chesemore

PubMed · 8909708

Prospects for FDA use of third-party certification.

Abstract

At the AAMI/Food and Drug Administration (FDA) International Standards Conference in March, Ronald Chesemore, associate commissioner for regulatory affairs at the FDA, explained the agency's rationale for several pilot programs announced the following week. The programs involve preannounced inspections, annotations of items on form FDA-483-List of Inspectional Observations (FDA 483), and postinspectional correspondence. The Associate Commissioner also discussed the advantages of implementation of a third-party inspection pilot program at a future date.

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Accreditation Certification Pilot Projects Product Surveillance, Postmarketing United States United States Food and Drug Administration Journal Article

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R Chesemore. Prospects for FDA use of third-party certification.. https://pubmed.ncbi.nlm.nih.gov/8909708/

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