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U.S. Department of Health and Human Services

About FDA

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Inspections

View PDF of the Inspections Section (49KB)

Background

Summary of Public Comments

Considerations

Transparency Report ArrowView All Inspections Draft Proposals

Draft Proposals

Draft Proposal 6

FDA should disclose the name and address of the entity inspected, the date(s) of inspection, type(s) of FDA-regulated product involved, and the final inspectional classification—Official Action Indicated (OAI), Voluntary Action Indicated (VAI), or No Action Indicated (NAI)—for inspections conducted of clinical trial investigators, Institutional Review Boards (IRB), and facilities that manufacture, process, pack, or hold an FDA-regulated product that is currently marketed.  The disclosure of this information should be timed so as not to interfere with planned enforcement actions.

Draft Proposal 7

FDA should generate, and share with the public, information about the most common inspectional observations of objectionable conditions or practices that are made during inspections of FDA-regulated establishments and post that information online on a regular basis.

 

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