Category Archives: FDAzilla

28 Unique Data Integrity Deficiencies That Aren’t Really Unique

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

We’ve all been following the health authority’s identified deficiencies in data governance and data integrity for the last few years, though this enforcement action has been ongoing for almost twenty years.  A comprehensive GMP Intelligence program follows 483s and warning letters for information on the FDA’s focus.  Particularly in this area, the best learning materials are often provided by the regulatory authorities like the FDA.  The early deficiencies in this area cited disagreement between data submitted to the FDA in a regulatory filing vs the original data identified at the site.  Most recently the use of ‘integration interruption’ capability of chromatography data systems has been identified as a means of data manipulation.  In addition, some firms have gone to extremes in physically blocking the FDA’s access to areas which they have a right to inspect.

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Is The FDA Changing Their Interpretation?

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

Why Didn’t the Internal GMP Audit Group Identify that Before the Health Authorities?

The FDA inspection observations continue to identify the shortcomings in many of the same areas over the last five or more years. That begs the question why.  Does the FDA rapidly shift its focus in that short a time period? Are they applying novel interpretations that the industry has not anticipated? Alternatively, is the internal GMP audit group focusing on the wrong areas?  Or is management downplaying the internal audit findings saying something along the lines of “The FDA has reviewed that program and not found any faults, so no, we’re not making any changes – particularly the costly ones.”  Let’s take a look at the various options.

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Our database now has 703,956 FDA inspections

Just a quick update – the FDAzilla Enforcement Analytics database was updated with data through April 25, 2017. We typically refresh the inspections data every 3 weeks or so, pair new warning letters with inspections every week, and add new 483s, EIRs, and 483 response letters every month.

As of now, our database has:

And the best part is that it’s all linked together.

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FDA Sent These 7 Warning Letters for Pharma Companies | April 2017

We took a snapshot of the 7 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from “products being misbranded” to sites “not ensuring that test procedures are scientifically sound.”

From pharmaceuticals in India, Pennsylvania, and more, here they are (starting with the most recent):
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When Will the FDA Move On from Data Integrity?

The FDA has been writing up companies on data integrity since the year 2000. Even after all the horror stories, and even after billions of dollars of market cap have been erased from it, here we are in 2017, still talking about it.

Here is some troubling text from recent Warning Letters that cite data integrity:

“…our investigator observed your warehouse supervisor tearing out pages from your firm’s annual report and placing the pages into his pocket.”

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2016 MHRA GMP Inspections yields 50% more deficiencies in key areas

MHRA Identified GMP Inspection Deficiencies,  2016

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

The MHRA published a large slide deck that addressed GMP deficiencies identified during inspections in 2016.  They published a slide deck of similar information for 2015 a few months ago.  In this blog, we look at some of the similarities and differences between the two years. The data only represent deficiencies noted for dosage forms and do not include those identified at inspections of API manufacturers.  We previously compared the FDA inspection observations for 2016 with the 2015 MHRA Deficiencies.  

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Warning Letters 2016 – Data Governance & Data Integrity

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

In 2015 we published a collection of FDA GMP warning letters that included deficiencies in data governance and data integrity.  Here we provide the same information for 2016 drug GMP warning letters. These should serve as a resource for GMP audit staff and QA staff as they evaluate their own firms and contract sites for gaps in these areas.  In this introduction, we provide tables and graphs identifying the dates of the warning letters, firms to which they were issued, and the country where the facility is located.  We also provide a table that shows the trends over time for location of countries where facilities receiving these warning letters were located, beginning in 2008.  And, finally, we provide a tabulation of the regulations most frequently cited for these deficiencies in 2015 and 2016.

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