What We Offer

Enforcement Analytics

Comprehensive FDA inspections and enforcement database

Imagine what your team could do with access to every FDA inspection since 2000, linked to the investigator, site, whether a 483 was issued or not, and any associated warning letters.

  • Find out exactly how any site or company has performed with FDA inspections.
  • Analyze data on every investigator and every inspection.
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FDA 483 Service

Thousands of inspection documents, quickly searchable and instantly available

An investigator shows up at 8am. With this tool, your team can have her available 483s and every 483 containing the words "sterile contamination" by the 10am break.

  • Instantly identify specific 483s by inspector, company, and even observation text.
  • Largest online library of 483s available immediately and anonymously.
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GMP Regulatory Intelligence

The only GMP regulatory and trending surveillance tool you need

Keeping up with regulatory intelligence is extremely time-consuming and frustrating. Let us do the work for you and deliver it in a comprehensive and concise weekly email.

  • One comprehensive, but succinct, synthesized weekly email to rule them all. It's not just content, we provide the context as well.
  • Your answer to the FDA investigator question, “How do you monitor external developments?”
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Analytics for Food Companies

FSMA is here. How will you manage 1,000 suppliers? With data.

  • Get the FDA inspections history of any site.
  • Stay informed of suppliers' recent FDA inspections.
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Inspection Monitoring

You choose the facilities. We monitor them for inspections and provide the inspection documents ASAP.

  • Be among the first to get the exact inspection documents you need.
  • Don't waste valuable time sifting through the data - we'll do that for you.
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Manufacturing Risk Intelligence (MRI)

For hedge funds, investment banks, and other financial institutions deeply vested in the pharmaceutical industry, MRI assesses the manufacturing risk of pharmaceutical companies. Now you can ensure your investments are properly positioned before manufacturing slip-ups occur.

  • Data + Expert-driven Assessment and Tiering of manufacturing risk.
  • Designed for investment firms deeply vested in biopharma.
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Documents

FDA 483s

FDA Inspectional Observations

Getting FDA 483s are a part of your core business, and FDAzilla has the most comprehensive library in the industry. With 8,000+ documents and more being added every month, you'll get the 483s you’re looking for.

  • Search the largest library in the industry by inspector, company, location, and date.
  • Get 483s in PDF format immediately and anonymously.
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INSPECTOR PROFILES

Inspect your inspector before they inspect you. Why not be as prepared as you can be?

  • Get the scoop on what your inspector’s previous inspections were like.
  • Find out if your inspector’s previous inspections led to any 483s and/or warning letters.
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EIRs

FDAzilla has added thousands of Establishment Inspection Reports (EIRs) to our inspection document library.

  • Search by inspector, company, location, and date.
  • Get EIRs in PDF format immediately and anonymously.
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SITE PROFILES

Performing due diligence on potential partners, collaborators, and acquisition targets? Get the low-down on their entire history of FDA inspections.

  • Get the key performance metrics and FDA inspection history on any site.
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