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# FDA Issues FDARA Inspection Report
- URL: https://www.fdaweb.com/fda-issues-fdara-inspection-report/
- Published: 2018-03-28T12:00:00.000Z
- Updated: 2026-09-14T23:55:45.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5141093

FDA has published the annual report on information related to inspections of facilities necessary for approval of a drug or medical device required by the 2017 FDA Reauthorization Act. The [report](https://www.fda.gov/downloads/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDARA/UCM598940.pdf?ref=fdaweb.com) shows that: 

- median time between inspection request from FDA staff reviewing a drug application or report to the beginning of the inspection was 102 calendar days;
- median time between beginning of inspection and issuance of FDA-483 was seven calendar days;
- median time between issuance of FDA-483 and regulatory or enforcement action was 169 calendar days;
- median time between inspection request from FDA staff reviewing a medical device application or report to the beginning of the inspection was 35 days; and
- median time between beginning of inspection and issuance of FDA-483 was five calendar days.