Category Archives: cGMP Quality Assurance and FDA 483s

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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Why is No One Talking About This? 2016 was the Year the FDA Exploded on China

New data synthesized by FDAzilla has revealed several dramatic shifts with FDA inspection and enforcement activity.

The FDA issued 15 pharma GMP-related warning letters to manufacturing sites in China in 2016 – a 5-fold increase from years prior. China averaged 2.7 Warning Letters per year from 2013 to 2015.  This explosion was led mostly by infamous FDA investigator, Peter Baker, who performed 17 inspections in China in 2016, leading to 13 FDA Form 483s and 4 Warning Letters. Continue reading

FDA Sent These 10 Warning Letters for Pharma Companies | January 2017

We took a snapshot of the 10 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from products not meeting “the definition and standard for chocolate” to sites “refusing to permit the FDA inspection” altogether.

From pharmaceuticals in Italy, Pennsylvania, and more, here they are (starting with the most recent):
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FDA Sent These 5 Warning Letters for Pharma Companies | December 2016

We took a snapshot of the 5 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from failing to put expiration dates on containers to failing to put soap in the bathrooms.

From pharmaceuticals in Canada, Spain, and more, here they are (starting with the most recent):
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An Alternative to GMP Quality System Auditing in the Pharma Industry

An Alternative to GMP Quality System Auditing in the Pharma Industry

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

Executive Summary:

  • Historically, a quality systems approach to GMP auditing has become common practice. However, this systems approach does not routinely address the essential input into the system – the data.
  • Data integrity issues have drastically increased in the last year – and not just in foreign warning letters.
  • Why would you do business with a firm whose data you can’t trust?

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FDA Sent These 7 Warning Letters for Pharma Companies | November 2016

We took a snapshot of the 7 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from failing to maintain complete data to failing to prevent microbiological contamination.

From pharmaceuticals in Japan, New Jersey, and more, here they are (starting with the most recent):
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