Category Archives: cGMP Quality Assurance and FDA 483s

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

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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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 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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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

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.

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 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:

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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.

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Data Integrity cGMP FDA draft guidance

FDA Draft Guidance on Data Integrity and Compliance With CGMP

by Barbara Unger, GMP Quality Expert and GMP Regulatory Intelligence Editor-in-Chief

 

The FR announced availability of the long awaited 10-page FDA draft Guidance on Data Integrity and Compliance with CGMP for comment.  I include links to the MHRA guidance HERE and the draft WHO guidance HERE for comparison.  The guidance is structured in a Q&A format with a total of 18 questions.  This guidance focuses heavily on identifying and citing the predicate rules as they apply to electronic records and data integrity, and for this it is an excellent reference.  In my opinion, though, the excessive citation of regulations detracts from the content and provides little insight into FDA’s intent and actual expectations in this area.

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Open Position at FDAzilla: Sales Administrator

Sales Administrator 

Our Company

FDAzilla is a fast-growing data analytics company that provides documents and data services to FDA-regulated companies in the pharmaceutical, medical drug and consulting industries. Our team is growing to meet the increasing demand for our services. We are seeking a sales administrator to handle the day-to-day administrative needs, sales support, customers service and management support. Someone who is analytical, detail-oriented, a team player, customer-focused, and can multi-task. This is part-time position (15-20 hours a week) with the opportunity to become full-time. Work from home.

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