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Search FDA Inspection Outcomes

Monitor FDA inspections and outcomes to surmize drug supply chain risk

List of recent FDA Inspections and Outcomes Over 1,000 records

Pharma Company FDA Inspection End Date FDA Registered Site City Country FDA Project Area FDA Inspection Classification

Search FDA Inspections

What is an FDA inspection?
The Food and Drug Administration (FDA) conducts inspections and assessments of regulated facilities to determine a firm's compliance with applicable laws and regulations, such as the Food, Drug, and Cosmetic Act and related Acts. After an inspection the is is either listed as No Action Indicated (NAI), Voluntary Action Indicted (VAI) or Official Action Indicated (OAI). NAI is the best outcome and OAI is the worst outcome. Continued issues can then further result in a warning letter or consent decree.

What is and FDA inspection with No Action Indicated (NAI)
An FDA inspection with NAI meands No actions indicated to the site after inspection.

What is and FDA inspection with Voluntary Action Indicated (VAI)
An FDA inspection with VAI means Voluntary actions indicated to the site after inspection.

What is and FDA inspection with Official Action Indicated (OAI)
An FDA inspection with OAI means Official action indicated by the FDA after inspection.

How should I use the FDA inspection list?
This is a good list to monitor for FDA inspection outcomes. Depending on the FDA inspection outcome you can use this in conjuction with other pharmaceutical competitive intelligence to surmize if there may be any drug shortage or drug supply impact due to the FDA inspection outcome. Too review FDA warning letters and 483s which may follow a poor FDA inspection see the following links.

Data Sources 200,000 records

Dailymed - Continuously Updates
OpenFDA - Continuous Updates
Federal Supply Schedule Pricing - Daily
Drugs@FDA - Weekly
Orange Book - Weekly
483s - Weekly
Warning Letters - Weekly
Drug Patents - Weekly
FDA Inspections - Weekly
DMF files - Quarterly
Data dependant on timing of updates to source data. WIZMED nor any of its agencies, contractors, subcontractors or employees does not make any warranties, expressed or implied, with respect to data contained in these databases or files, and, furthermore, assume no liability for any party's use, or the results of such use, of any part of the database or files.