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

Inadequate Media Fills at a Sterile Manufacturer When Starting up After a Shutdown: CGMP Inspection Case Study by FDA National Drug Expert Ileana Barreto-Pettit

FDA National Drug Expert Ileana Barreto-Petit presents an in-depth analysis of the findings, lessons learned, and how companies can avoid similar findings in regard to a CGMP inspection case study. This case study involves a large, foreign manufacturer of injectable drug products. The product in question is a combination product.

READ MORE

Champion of Change – 3Cs to Success

Join Govzilla and corporate QA External Engagement Leader, Keynote Speaker, and Leadership Coach, Steve Greer, for an empowering webinar on being a Champion of Change and using the 3Cs to Success in your personal life and organization.  

READ MORE

Cleaning and Cross-contamination Issues with an Encapsulator: CGMP Inspection Case Study by FDA National Drug Expert Ileana Barreto-Pettit

At the International GMP Conference at the University of Georgia in Athens, Georgia, in early March 2020 co-sponsored by FDA, FDA Office of Regulatory Affairs National Drug Expert Captain Ileana Barreto-Pettit presented FDA drug GMP warning letter trends over recent years and provided in-depth case studies from Current Good Manufacturing Practice (CGMP) inspections. This first study, presented here, focuses on cleaning and cross-contamination issues with an encapsulator.

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
Govzilla 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

Inadequate Media Fills at a Sterile Manufacturer When Starting up After a Shutdown: CGMP Inspection Case Study by FDA National Drug Expert Ileana Barreto-Pettit

FDA National Drug Expert Ileana Barreto-Petit presents an in-depth analysis of the findings, lessons learned, and how companies can avoid similar findings in regard to a CGMP inspection case study. This case study involves a large, foreign manufacturer of injectable drug products. The product in question is a combination product.

READ MORE

Champion of Change – 3Cs to Success

Join Govzilla and corporate QA External Engagement Leader, Keynote Speaker, and Leadership Coach, Steve Greer, for an empowering webinar on being a Champion of Change and using the 3Cs to Success in your personal life and organization.  

READ MORE

Cleaning and Cross-contamination Issues with an Encapsulator: CGMP Inspection Case Study by FDA National Drug Expert Ileana Barreto-Pettit

At the International GMP Conference at the University of Georgia in Athens, Georgia, in early March 2020 co-sponsored by FDA, FDA Office of Regulatory Affairs National Drug Expert Captain Ileana Barreto-Pettit presented FDA drug GMP warning letter trends over recent years and provided in-depth case studies from Current Good Manufacturing Practice (CGMP) inspections. This first study, presented here, focuses on cleaning and cross-contamination issues with an encapsulator.

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