Category Archives: Form FDA 483

Inspect your FDA Inspector Before Your Inspection

Today, I’m excited to officially announce a new set of services to help you prepare for your next FDA inspections – FDA Inspector Profiles.

We’ve taken 16+ years of FDA inspection data and combined it with other relevant databases to bring you a comprehensive, detailed look into any individual FDA Inspector. Continue reading

The Story of 3 Consent Decrees

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

A consent decree agreement is an agreement filed in the US courts formalizing a voluntary agreement between two parties.  Here we will address consent decree agreements between FDA and several pharmaceutical companies based on repeated failures to adequately address CGMP deficiencies.  It is not an action taken on the basis of a single form 483, or a single warning letter.  Generally, a series of events play out over time when critical inspection observations are not addressed and are identified in subsequent inspections.  Frequently one or more warning letters are involved.  Consent decree agreements often include fines, with the option for additional financial penalties if conditions to which the firm agrees are not met.  Often these firms are required to use a 3rd party consultants to perform lot release.  Firms operating under a consent decree agreement have largely lost their independence in GMP activities.  Unlike Corporate Integrity Agreement which have a defined duration, firms must petition to have the consent decree agreement condition rescinded.

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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

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

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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PRESS RELEASE: New Data Provides FDA-Regulated Industries Unprecedented Insights Into FDA Inspection Trends and Enforcement Actions

CHICAGO, IL – May 14, 2015

FDA Inspections at a glanceToday, FDAzilla unveiled Enforcement Analytics, a ground-breaking data analytics tool that gives industry greater insights into FDA enforcement actions and inspection activity.  For the first time in the industry, data on FDA inspections, FDA inspectors, Form 483s, manufacturing sites regulated by the FDA, and FDA warning letters are all linked together, creating huge potential for industry insight.

“Smart data has arrived onto FDA inspections.  We are proud to unveil Enforcement Analytics today, a much-needed innovation in the regulatory space for the thousands of professionals who work on keeping their manufacturing processes up to snuff for the FDA,” said Tony Chen, co-founder and CEO of FDAzilla. Continue reading