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Haven’t visited us for a while? Get up to speed in 4 minutes

If you haven’t been to FDAzilla.com in a while, then you’ve come to the right place. If any part of your job involves preparing your company for FDA GMP inspections, let me take you on a quick tour of some tools and resources that you might find useful!

Take 4 minutes and check out these 4 things:

  1. DECREASE YOUR RISK WITH DATA: Companies like P&G, Altria, AbbVie, Novartis, Astellas, and many others now count on accessing a new data analytics tool called Enforcement Analytics. Imagine being able to “google” FDA inspections and inspectors. Here’s a short video.
  2. INSPECT YOUR INSPECTOR: FDA inspector coming on Tuesday? Or worse yet, she’s in your conference room right now?  You can get her inspector profile, which includes her most frequently cited CFR code, most frequent co-inspectors, enforcement metrics, and inspection history. In just the last few weeks, customers from 3 continents have purchased these in preparation for an upcoming (or current) inspection.
  3. READ FRESH INSIGHTS: The blog you’re on now is a treasure trove of resources and insights from me (Tony Chen, CEO of FDAzilla) and Barbara Unger, GMP Quality Expert, who has been in your shoes. Why not start here – our 14 most popular posts of all time. If you feel that getting needed info is like finding a needle in a haystack (or drinking from a firehose!), let us do the work for you. Get our comprehensive, succinct weekly synthesis of the latest GMP regulations, guidelines, enforcement actions, and developments here.
  4. GET 483s (AND NOW EIRs): The FDAzilla store houses 7,000 483s, with hundreds added every month. We’ve also just added 2,000 EIRs and 150 483 response letters. If you’re a heavy 483 user, you should also consider our 483 service.

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence. Contact Ben if you ever have questions at ben@FDAzilla.com.

Huge Cost of a GMP Failure

What Does Getting an 483 or Warning Letter Really Cost You?

“Forget about actual warning letters. The cost of us receiving a moderately bad 483 is roughly $250,000.”

I heard this from a reputable Head of Manufacturing of one of the largest biopharma companies in the world.  While most pharma and med device companies seems to learn quickly from everyone else’s mistakes, companies still occasionally get a “moderately bad” 483.  And then what happens after that? Continue reading

Copy of My Inspectors are More Rigorous Than Yours

EU vs. FDA: My Inspectors are More Rigorous Than Yours

by Barbara Unger, FDAzilla GMP Quality Expert

FDA and the EU have taken serious enforcement actions against several firms in the others geographic jurisdiction in calendar year 2016.  Perhaps this flurry of my-inspectors-are-more-rigorous-than-yours type represents an unofficial test of sorts as these two agencies move to rely more on each other’s inspections.   These inspections may test the limits and validity of the underlying assumption that would permit this mutual recognition.  Also interesting is that the European inspections specifically evaluate investigational product manufacture, something FDA does not generally do except on a for-cause basis.  Below we cover the three EU reports of GMP non-compliance issued regarding sites in the US and three FDA warning letters, one FDA import alert, and one untitled letter issued regarding sites in the EU.

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2,000 EIRs

We Just Added 2,000 EIRs into Our Store

Due to popular demand, we have decided to add EIRs into our store. Establishment Inspection Reports (EIRs) are an important tool in your tool belt of inspection preparation and intelligence. If you aren’t familiar with them, read our recent post on the 5 Things to Look for in an EIR. Continue reading

5 Features about EIRs

5 FEATURES TO LOOK FOR IN AN EIR

Benjamin Franklin said, “By failing to prepare, you are preparing to fail.”  Prepare for your FDA inspections with Establish Inspection Reports (EIR).  An EIR is the full report of an FDA inspection written by the investigators.  Among the features identified in the report are:

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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.  Continue reading

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