Author Archives: Tony Chen

About Tony Chen

Tony Chen is Chairman of FDAzilla

FDA Sent These 9 Warning Letters for Pharma Companies | July 2017

We took a snapshot of the 9 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from “adulterated and misbranded drug products” to sites “failing to sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination.”

From pharmaceuticals in Italy, Tennessee, and more, here they are (starting with the most recent):
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FDA Sent These 5 Warning Letters for Pharma Companies | June 2017

*August 3 update: we added 2 additional warning letters that were released by the FDA after we published this post on July 12, 2017.*

We took a snapshot of the 5 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from “misbranded products” to sites “failing to investigate the unexplained discrepancy.”

From pharmaceuticals in China, Texas, and more, here they are (starting with the most recent):
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FDA Sent These 6 Warning Letters for Pharma Companies | May 2017

We took a snapshot of the 6 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from failing to establish adequate written procedures to not submitting periodic adverse drug experience reports.

From pharmaceuticals in New Jersey, China, and more, here they are (starting with the most recent):
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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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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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FDA Sent These 8 Warning Letters for Pharma Companies | March 2017

We took a snapshot of the 8 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from failing to monitor the water purification system to personnel not wearing appropriate clothing to prevent contamination.

From pharmaceuticals in California, Singapore, and more, here they are:
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