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  1. Inspection References

FDA's Remote Oversight Tools

The FDA leverages remote tools to assess human and animal drug and some biologic sites using its authority under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act which allows records to be requested in advance or in lieu of an inspection. In commodities where the FDA does not have authority, the FDA is using voluntary participation of firms to review records via remote regulatory assessments, and other information from human and animal drug manufacturers.

Remote Regulatory Assessment Fact Sheets

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