FDA inspections at a glance by FDAzilla

Infographic: The Story of FDA Inspections

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ABOUT FDAZILLA
FDAzilla offers a variety of services to help you work smarter with FDA data, particularly in the areas of inspection preparation and regulatory intelligence.

Reports & Documents

  1. 483s – the largest searchable library of 483s anywhere.
  2. Inspector Profiles – Inspect your inspector before your inspection. Get their full inspection histories and key inspector metrics.
  3. Site Profiles – Get any site’s entire FDA inspection and enforcement history.
  4. Custom Requests – Let us request 483s and/or EIRs on your behalf.

Subscriptions – Individual subscriptions are $1,995/year each 

  1. FDA 483s – Get unlimited access to download 483s from our library, the largest online repository in the industry.
  2. GMP Regulatory Intelligence – This unique weekly newsletter scans and synthesizes drug GMP regulatory guidance, developments, and enforcement actions – here and in the EU. 

Corporate subscription options are available.

Premium Subscriptions
  1. Inspection Monitoring – You pick the sites, and we monitor them each month. If an inspection occurs, we will find out and obtain the 483 and/or EIR for your team.
  2. Enforcement Analytics – Groundbreaking data analytics tool that is the only source in the world that links 15 years of data on inspections, sites, inspectors, 483s, and warning letters.
  3. Full-Text 483 Search – Search tens of thousands of fully-searchable 483 observations so you can zero in on exactly what you need.

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence. Contact me if you ever have questions at tony@fdazilla.com.

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