SEARCH LESS KNOW MORE The essential tool for regulatory, compliance, and quality professionals

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SITE PROFILES

SEE THE COMPLETE PICTURE

Quickly assess a site’s 483 issue rate, Warning Letters, and aggregated CFR Citations—all in one place.

TAGGED & SEARCHABLE DATA 

FOCUS ON THE DATA THAT MATTERS

All in-stock 483s have been retyped and tagged with keywords to help you quickly analyze the data you are interested in.

Filter searches by industry keywords and site tags.

Segment by FDA Industry, region, document type, and more.

INSPECTOR PROFILES

KNOW WHERE TO CONCENTRATE YOUR EFFORTS

Identify the most common issues and focus areas.

Link to all inspections and citation data.

Reveal most-common co-inspectors.

TRENDS & BENCHMARKS

ELIMINATE UNWANTED SURPRISES

Benchmark performance relative to your peer group, which creates the business case for preemptive corrective actions.

Be one step ahead of the FDA by determining key areas of focus. 

Align your budget and CAPAs to the top issues and emerging trends.

LATEST BLOG POSTS

FDA Warning Letters Week of 3/22/2020: OTC and HCT/P

In the areas we cover, FDA posted three drug GMP warning letters including one sent to a fertility clinic governed by HCT/P regulations.  The other two firms manufacture OTC products.  FDA also posted a warning letter to a firm in Ireland, Carahealth, for distributing unapproved and misbranded products related to coronavirus disease.

READ MORE

EMA Announcements Regarding Nitrosamine and MDRs

The EMA published information on two topics this week addressing changes in due dates and application dates regarding nitrosamine-related risk assessments and implementation of the new Medical Device Regulation (MDR) requirements.

READ MORE

Part 3: MHRA GMP Inspection Deficiencies for 2018

Published in late 2019, MHRA’s 2018 GMP inspection deficiency data spans over 6,000 lines of a spreadsheet. GMP expert Barbara W. Unger evaluated the data and presents a data-dense report of her findings and deficiency trends since 2015.

READ MORE

What is being said about Govzilla

This is a powerful analytics tool we use routinely across the full GxP spectrum to monitor supply chain risks, assess vendors, and clinical trial sites. The analytics allow for effective and efficient compliance benchmarking and QMS planning in an easy to use format.
Judith Sernatinger
VP, Global Head of Quality at Prothena Corporation
FDAzilla is an unrivaled source of data for everything related to FDA inspections: inspectors, inspectional findings, manufacturing plants. I could not have written Bottle of Lies without it.
Katherine Eban
Investigative Journalist
FDAzilla is an essential tool for our quality unit. I know our team will be fully prepared if an investigator arrives at our facility tomorrow. No guesswork here. With a simple search I can have enforcement trends by specific keywords presented quickly and clearly.
Cylia Chen
Director of Quality at Amgen

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SEARCH LESS KNOW MORE
The essential tool for regulatory, compliance, and quality professionals

SEARCH LESS KNOW MORE
The essential tool for compliance, regulatory, and quality professionals

SITE PROFILES

SEE THE COMPLETE PICTURE

Quickly assess a site’s 483 issue rate, Warning Letters, and aggregated CFR Citations—all in one place.

TAGGED & SEARCHABLE DATA 

FOCUS ON THE DATA THAT MATTERS

All in-stock 483s have been retyped and tagged with keywords to help you quickly analyze the data you are interested in.

Filter searches by industry keywords and site tags.

Segment by FDA Industry, region, document type, and more.

INSPECTOR PROFILES

KNOW WHERE TO CONCENTRATE YOUR EFFORTS

Identify the most common issues and focus areas.

Link to all inspections and citation data.

Reveal most-common co-inspectors.

TRENDS & BENCHMARKS

ELIMINATE UNWANTED SURPRISES

Benchmark performance relative to your peer group, which creates the business case for preemptive corrective actions.

Be one step ahead of the FDA by determining key areas of focus. 

Align your budget and CAPAs to the top issues and emerging trends.

BLOGS

FDA Warning Letters Week of 3/22/2020: OTC and HCT/P

In the areas we cover, FDA posted three drug GMP warning letters including one sent to a fertility clinic governed by HCT/P regulations.  The other two firms manufacture OTC products.  FDA also posted a warning letter to a firm in Ireland, Carahealth, for distributing unapproved and misbranded products related to coronavirus disease.

READ MORE

EMA Announcements Regarding Nitrosamine and MDRs

The EMA published information on two topics this week addressing changes in due dates and application dates regarding nitrosamine-related risk assessments and implementation of the new Medical Device Regulation (MDR) requirements.

READ MORE

Part 3: MHRA GMP Inspection Deficiencies for 2018

Published in late 2019, MHRA’s 2018 GMP inspection deficiency data spans over 6,000 lines of a spreadsheet. GMP expert Barbara W. Unger evaluated the data and presents a data-dense report of her findings and deficiency trends since 2015.

READ MORE

What is being said about Govzilla

This is a powerful analytics tool we use routinely across the full GxP spectrum to monitor supply chain risks, assess vendors, and clinical trial sites. The analytics allow for effective and efficient compliance benchmarking and QMS planning in an easy to use format.
Judith Sernatinger
VP, Global Head of Quality at Prothena Corporation
FDAzilla is an unrivaled source of data for everything related to FDA inspections: inspectors, inspectional findings, manufacturing plants. I could not have written Bottle of Lies without it.
Katherine Eban
Investigative Journalist
FDAzilla is an essential tool for our quality unit. I know our team will be fully prepared if an investigator arrives at our facility tomorrow. No guesswork here. With a simple search I can have enforcement trends by specific keywords presented quickly and clearly.
Cylia Chen
Director of Quality at Amgen