FDAzilla’s Top 14 Posts of all Time

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. 

  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 years of 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. 5 Features to Look for in a Form 483 – 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.

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

Leave a Reply

Your email address will not be published. Required fields are marked *