Our Best Thus Far (2)

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.

6 Data integrity 483s

To Understand Data Integrity, Just Read These 6 FDA 483s

I asked Barb Unger a difficult question, “If you could just pick 6 483s to understand this Data Integrity problem, which 6 would you pick? And why?”  Here is her response.

From Barb:

As we continue to follow the data integrity story, let’s take a look at six (6) forms 483 associated with data integrity that had broad impact throughout the industry or resulted in serious enforcement actions including consent decree agreements. You will see that they are not limited to a single country and many of the observations are similar or exactly the same over a decade. Continue reading

Check out the new Enforcement Analytics video

If part of your job involves preparing for inspections or analyzing FDA cGMP inspection trends, you should watch this video:

 


Any questions? Want to get a live demo for you or your team? Contact Ben Anderson at ben@FDAzilla.com.

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483s, Inspector Profiles, Enforcement Analytics, and GMP Regulatory Intelligence.

New FDAzilla.com

Welcome to the new FDAzilla.com

Times are changing. We now live in a world where we have too much information and way too much raw data, but not enough wisdom.  More and more often, a lot of answers isn’t as useful as one good question. Isn’t the same true for our field of inspection preparation and regulatory intelligence. Why can’t we apply new data and word analysis technologies so that our teams can more effectively reach our quality goals? That’s where we’re headed at FDAzilla.  Continue reading

5 Things_Warning Letter

5 FEATURES TO LOOK FOR IN A WARNING LETTER

5 FEATURES TO LOOK FOR IN A WARNING LETTER

Warning letters are the FDA’s second level of enforcement actions after issuance of a form 483. The FDA determined that either the firm’s response to the form 483 was inadequate or the observations were serious enough to support issuance of a warning letter.   Often it is possible to determine the corrective actions necessary and the impact that the warning letter will have on the business.  To determine a letter’s impact on the business, I ask these questions:

Continue reading

Five Features to Look for in FDA Form 483s

5 FEATURES TO LOOK FOR IN AN FDA FORM-483

 5 FEATURES TO LOOK FOR IN AN FDA FORM-483

A form-483 is the document that FDA issues at the close of an inspection where they identify observations made during the inspection.  If no observations have been made, no form 483 is issued. Based on the response submitted by the firm, FDA classifies the inspection as:  No Action Indicated (NAI) when no form 483 is issued, Voluntary Action Indicated (VAI) or Official Action Indicated (OAI).  In general, where FDA issues a form-483 with observations and the firm’s response is satisfactory, the inspection is classified VAI.

Continue reading