Over the years, the FDAzilla blog has published almost 300 articles. We’ve acquired a lot of new readers since we started writing here in 2010. With these newer followers in mind, FDAzilla has assembled a list of some of our most useful articles. To put together this collection, we considered which posts have been the most searched-for and viewed over time, and evaluated these popular posts for helpfulness and continued relevance.

We hope this compilation will serve as a resource for you and your company. It should also help orient you to the scope of the FDAzilla blog as you continue to follow our efforts to provide accessible FDA data and insights. 

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  1. 3 Types of FDA Inspections – Is your inspector coming for a PAI, routine, or for-cause inspection? This is our most popular post of all time.
  2. Who Can See FDA Form 483s and Where Do I Get Them?  – 483s are accessible to anyone who knows how to ask for them, but there are some important nuances to be aware of.
  3. What’s the Big Deal with FDA Form 483s? – Need an introduction to the basics of FDA 483s? This post has you covered.
  4. How to Respond to FDA 483s  – Do you know the 4 parts of an effective 483 response? Have you considered what to do during an inspection – before receiving a 483, or afterwards – once your company has replied to the FDA’s objections? 
  5. Data Integrity: The Whole Story – The FDA has a long history of issuing serious enforcement actions for data integrity violation. Monitoring certain data can protect your company from financial and reputation-taxing consequences. 
  6.  7 Strategies to Avoid FDA 483s – You need to know how to deal with 483s when they occur, but you’re probably more eager to skip them altogether. Learn how to prepare for inspections now, and you won’t be responding to FDA observations later. 
  7.  Infographic –  What kind of inspection doubled from 2011-2014? How much experience does the average FDA inspector have? This infographic, the only one of its kind, compiles data to provide details on the last 15 yearsof FDA inspections.
  8.  How 483s are Written – There are 10 questions we are frequently asked about the lifecycle of 483s. Our answers are based on synthesized FDA manuals and data. What should you expect from your inspections?
  9. 6 Features to Look for in FDA 483s – Knowing where to direct your focus will enable you to draw conclusions and make predictions as you read 483s. Do you know which details are key?
  10. 4 Trends About GMP Inspection Readiness and FDA Data Intelligence  – Our industry is always evolving, and it’s important to keep up. Here are some of the developments FDAzilla has been watching since 2015. Eerily enough, these are still relevant for us today — and we think they’ll matter to you, too. 
  11. Does an FDA Import Alert Automatically Equate to an Impending Warning Letter?  – How strongly correlated are Warning Letters and Import Alerts? GMP Quality Expert Babara Unger has tabulated FDA data on Import Alerts and associated Warning Letters. We use this information to determine the statistical strength of the relationship.
  12. New Question FDA Inspectors May Ask at Your Next Inspection – GMP Intelligence programs — which enable companies to monitor regulation and guideline changes — have always saved you money. Now FDA and EU regulators require them. 
  13.  The Story Behind FDAzilla – We established FDAzilla around a central goal: making valuable FDA data more usable and available to those who need it. Learn more about what drives our company today, and what we’ve learned from you over the years.
  14. Tales From The Front: With the FDA in Costa Rica – There are some things we all have in common: as much as we try to avoid them, we are all prone to mistakes — especially in situations that involve language or cultural barriers. Thankfully, it’s probably less than likely that your inspection mishap will involve accidentally leaving your inspector in the middle of a jungle! We love this FDA inspection story that’s both outrageous and relatable.

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Comparing and Analyzing Russian, UK, and US Top Ten Pharma Inspection Findings FY 2019

Webinar: Comparing and Analyzing Russian, UK, and US Top Ten Pharma Inspection Findings FY 2019

Presented by Jerry Chapman on October 29, 2020

What you will learn:

  • A comparison of 483 observations in FY2019
  • Top 10 Russian Ministry of Health inspection findings
  • Top 10 FDA Warning Letter findings
  • Top MHRA inspection findings
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INDEX INFORMATION  Redica consolidates regulatory data in real-time on the single largest database for quality, safety, and compliance intelligence.

STRENGTHEN DATASETS Redica machine intelligence algorithms identify and triage risk signals to derive meaning from vast amounts of private and public data.

ANALYZE & INTERPRET PATTERNS Redica instantly models the customer-specific regulatory risks, trends, and opportunities that stand to fundamentally change compliance operations.

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Evaluate Your CDMOs

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Compare the inspection history of your CDMO sites.

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Compare the enforcement history of your CDMOs.

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Monitor compliance at your Clinical Investigator sites.

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Prepare for inspections of Clinical Investigator sites.

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Prepare for your next inspection.

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Prepare for your next inspection.

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Prepare for your next inspection.

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Download your copy of THE FDA INSPECTION LANDSCAPE IN MID-2020 AND A LOOK AT VIRTUAL INSPECTION

In this summary we identify:

  • Trend analysis of FDA inspections through mid-2020
  • Strategies for preparing and hosting virtual inspections
  • New technologies to support remote inspections

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In this summary we identify:

FY2018-FY2020 GMP data for Lonza & Catalent

Top GMP primary citations

Top FDA 483 observations

Panel Discussion – Remote Audits

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Featuring Panelists:
—Barbara W. Unger, Unger Consulting, Inc.
—Jerry Chapman, Redica Systems
—Stephanie Gaulding, Pharmatech Associates

Who Will Benefit?
This session will be valuable to GMP quality, regulatory, compliance, and management personnel in FDA-regulated industries who want to have a conversation on remote audits and get to know what is going on in the industry.

Turning Failure into Success

Presented on Tuesday, April 27, 2021 by Steve Greer, Executive Coach, Genesis Assist, and former Quality Leader, Procter and Gamble

What you will learn:

  • How to use the Leadership SOS Model to transform quality culture
  • How to strengthen quality systems to eliminate human error
  • How to generate ideas on how to set your organization up for success for shareholders, FDA, and staff
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Quality Management Systems for Small Pharma and Biotech Firms

Webinar: QMS for Small Pharma and Biotech Firms

Presented by Fenton Fong, Founder, Managing Director, & Principal at xCellarate

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What you will learn:

  • Common challenges small pharma firms face when developing a QMS
    Recent enforcement trends involving the Quality Unit
    Impact of the COVID-19 pandemic

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In this summary we identify:

GMP data from FY2017 to FY2020 for the Asia-Pacific region

Top 3 GMP primary and secondary citations

Top 3 483 observations

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An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

In this summary we identify:

  • Data from 2019 UK MHRA Inspections
  • Trends from 2015, 2016, 2018, and 2019 inspections
  • Conclusions drawn from an analysis of drug inspection data

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SEARCH Find the inspection records you want by inspector’s name, company name, site, city, country, etc.

WARNING LETTERS Easily search the largest database of FDA Warning Letters by date, company, FDA office, or subject

SITES Quickly assess inspection records including dates and inspectors across all of your sites

INSPECTIONS Complete list of FDA inspections by date, company, category, and country

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Champion of Change - 3Cs to Success

Webinar: Champion of Change - 3Cs to Success

Presented by Steve Greer on June 23, 2020

What you will learn:

  • The 3C Model to become a champion of change
  • How to identify game-changing habits and the steps to implement them
  • Ways to develop greater purpose-centered leadership
  • How to generate awareness along with actions to create changes in how you think about challenges and change putting you on a path to lead change successfully in your organization
  •  

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5 GMP Case Studies Report

What You Will Learn from This Report:

The first countrywide import alert issued by FDA

An inadequate deviation investigation

An inadequate product specifications and a product recall

Process validation issues at a CMO

A different perspective on process validation and the culpability of the quality unit

 

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What You Will Learn from This Report:

How a major pharmaceutical company designed a program to train future leaders in quality

An industry-led initiative to advance the state of quality in the pharma industry

A pharma GMP leader’s tips for supporting quality culture within an organization

An update on FDA’s Quality Maturity Model

Impact of the Global Pandemic on Recent Data Integrity and Regulatory Non-compliance Trends

Webinar: Impact of the Global Pandemic on Recent Data Integrity and Regulatory Non-compliance Trends

Presented by Paul Smith, Agilent Technologies on Aug. 26, 2020

What you will learn:

  • Examples of essential laboratory actions to remain compliant during the pandemic
  • Recent data integrity non-compliance findings and trends
  • Essential strategies to find, understand, and leverage regulatory non-compliance data

Past, Present, and Future of Quality Culture

Presented by Regulatory Compliance Associates Distinguished Fellow Susan Schniepp

What you will learn:

  • How the 2014 FDA quality metrics initiative led to greater focus on quality culture
  • New quality culture tools and standards under development by PDA and other organizations
  • Best practices for quality culture, including case studies with lessons learned

Changing Medical Device Regulations

Presented by Redica Systems 

What you will learn:

  • The latest developments regarding the EU MDR
  • Quality Systems requirements for medical devices
  • Regulatory updates affecting medical devices

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Combination Product Report

What You Will Learn from This Report:

The latest U.S. and European regulatory developments

The impact of smart combination products

How the EU MDR impacts drug-device combination products

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5 GMP Case Studies Report

What You Will Learn from This Report:

In-depth analysis of the findings

Lessons learned

How companies can avoid similar shortcomings.

Experience the Power of Redica Systems

Redica Systems Expert Jerry Chapman to Present at SQA Annual Meeting

Index Information Redica consolidates regulatory data in real-time on the single largest database for quality, safety, and compliance intelligence.

Strengthen Datasets Redica machine intelligence algorithms identify and triage risk signals to derive meaning from vast amounts of private and public data.

Analyze & Interpret Patterns Redica instantly models the customer-specific regulatory risks, trends, and opportunities that stand to fundamentally change compliance operations.

Download the 510(k) Sample

What You Will Learn from This Sample:

See how a 510(k) submission is structured

Find out what information to include

Review correspondence between sponsor and FDA

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A.I. for Quality and Compliance Teams

August 3 webinar

Presented by Redica Systems Senior GMP Quality Expert Jerry Chapman

What you will learn:

  • A basic understanding of data sources, machine learning, NLP, and A.I. tools
  • Building and applying Expert Models
  • Two case studies, one on sterile manufacturing/503B and one on data integrity
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Get the scoop on recent data integrity 483 observations!

  • FY 2020 Data Integrity 483 Observations
  • Data Integrity Observations for Human Drugs
  • Observations Falling Under GMP
  •  

Human Factors – Compliance and Applications

June webinar

Presented by Alison Sathe, Founder, Regulatory Mark & Valerie Fenster, Director of Insights and  Human Factors, Kaleidoscope Innovation 

What you will learn:

  • Human factors strategies from simple drug products to complex surgical devices
  • Primary and secondary labeling development and evaluation for usability
  • Human factors activities from product development to post-market
  • International strategies: expectations for human factors in regulatory submissions in international markets

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Keep up with the latest Regulatory Developments on Clinical Trials

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Save your team valuable time when using External Monitoring.

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See how we can help you eliminate yet another spreadsheet.

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Stay ahead of changing regulations.

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