Category Archives: Form FDA 483

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

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

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

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THE FDA HAS HAD A BUSY 15 YEARS

15 Years of FDA Inspection Data: Infographic

Up until recently, it has been difficult to get data on FDA inspections. Sure, the FDA publishes aggregate data every year, but what about the granular data on every inspection? Over the past year, we’ve worked to get at this data and published this first infographic focused on FDA inspections.

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As you might imagine, the FDA has had a busy 15 years. Over that time period, they conducted 600,000+ inspections spanning 150,000+ facilities, issuing 130,000+ FDA 483s, and utilizing 4,500+ inspectors.

THE MIX OF FDA INSPECTIONS HAS CHANGED DRASTICALLY
Looking at the inspections year by year, FDA has gradually ramped up the number of inspections each year, starting at around 30,000 in 2000, and peaking at 46,000 in 2011. 483s issued roughly mirrored that trend as well.

Inspection duration has roughly stayed at about 3-4 days, though 3.8 days in 2014 was an all-time high. This could potentially be due to the increased focus on international inspections, which have tripled over the last six years. This is possibly the key take-away from this infographic.

International inspections remained constant – at around 800-900 from 2000 to 2008. An obvious, intentional shift in strategy began in 2009, which corresponds to a changing of the guard (Commissioner Hamburg took over for Commissioner Eschenback). Nonetheless, this is not a surprise, as the FDA has publicly announced this increased intensity overseas to match the volume of pharmaceuticals manufactured overseas.

We have seen this very clearly in our business as well. More and more of our customers are coming from overseas, as they prepare for their FDA inspections, sometimes for the first time. Just last week, customers from Turkey and Taiwan contacted us on the same day.

FDA INVESTIGATORS: LOTS OF VETERANS & ROOKIES
Looking specifically at the inspector data is also quite interesting. Out of the 4,500 inspectors utilized over the last 15 years, only 1,500 are active. That means 1,500 inspectors have inspected at least one facility in the last 12 months. As we looked at this data, it seemed that many of the inspections from 2000 to 2005 utilized inspectors that only inspected one facility. Perhaps the FDA transitioned strategies to dedicated inspectors as time passed.

These active inspectors have inspected an average of 122 facilities. Despite a massive hiring surge of new inspectors, there is still a large contingent of very experienced inspectors in the field – almost 750 inspectors have inspected at least 101 facilities. There are also a lot of “rookies”, with 177 inspectors with 4 or less inspections under their belts. Of course, these rookies are getting mentoring and in-the-field training from their more experienced counterparts.

All in all, we expect to see the FDA continue to ramp up international inspections, using their most experienced inspectors to lead those inspections. What do you see in these numbers?

All of this data is interesting for an infographic, but the true value lies in the specifics. We have all this granular data about inspections linked with inspectors, sites, 483s, and warning letters.  Now, you can drill down into a specific inspector or site or area – and see related 483s and warning letters. If you are interested in  slicing and dicing this data , please check out Enforcement Analytics.

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

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