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U.S. Department of Health and Human Services

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Inspections - Considerations

View PDF of the Inspections Section (49KB)


Background

Summary of Public Comments

Transparency Report Arrow Considerations

View All Inspections Draft Proposals  


Considerations
The Task Force recognizes that disclosing more information about FDA’s inspectional findings will be helpful to industry seeking to comply with applicable laws and regulations.  In addition, additional disclosures may provide the public with a better understanding of the supply chain for FDA-regulated products and inform decisions, by both consumers and industry, about which firms to purchase products from.

The Task Force considered the risk that the public may draw conclusions about firms based solely on the list of observations from the investigator’s report though FDA may conclude that observations noted in a FDA Form 483 do not affect the public health and further action is not required.  In addition, the Task Force considered that in FY 2008, FDA conducted approximately 14,800 inspections of foreign and domestic facilities that resulted in the issuance of an EIR.  With additional funding, the Agency will conduct more inspections in the future, which will likely result in the issuance of more inspection reports. 

The Task Force considered whether the usefulness of the inspection information would diminish if it was not provided in a timely fashion.