Author Archives: Tony Chen

About Tony Chen

Tony Chen is Co-Founder of FDAzilla

Warning Letters

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):
Continue reading

Warning Letters

FDA Sent These 6 Warning Letters for Pharma Companies | October 2016

We took a snapshot of the 6 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from allowing unauthorized access to confidential data to forgetting to put expiration dates on drugs.

From 3 pharmaceuticals in the USA and 3 abroad, here they are (starting with the most recent):
Continue reading

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

COMPARISION OF EMA and FDA Guidance on Data Management and Data Integrity

COMPARISION OF EMA and FDA Guidance on Data Management and Data Integrity

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

 

Major regulatory authorities published guidance addressing data management and data integrity in 2015 and 2016.  Two of the guidances, the draft from FDA published in April 2016 and the guidance from EMA posted in August 2016, take a Question and Answer approach.  The guidance from MHRA (HERE and HERE), PIC/S and WHO take the more standard narrative approach to regulatory guidance.  That having been said, all of the guidance documents are markedly similar in their overall expectations.  In this blog entry we look at the EMA and FDA Question & Answer guidances, the next entry will look at guidance from the other three authorities.

Continue reading

Warning Letters

FDA Sent These 8 Warning Letters for Pharma Companies | September 2016

We took a snapshot of the 8 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from a product containing “hair and a black spider” to management failing to “document laboratory controls.”

From pharmaceuticals in Japan, Brazil, and more, here they are (starting with the most recent):
Continue reading

October: FDA cGMP Quality News Briefing

What industry news have you been reading this month? At FDAzilla, we’ve compiled the most noteworthy articles we’ve come across in the weeks since our last update. This month’s picks include information from two conferences, surprising warning letters abroad and in the US, an explanation QSIT protocol, and stories of both exemplary and reprehensible strategies from companies dealing with in-house deficiencies. Take a look:

Continue reading

Interval Between Inspection and Warning Letters Starts to Decrease

Interval Between Inspection and Warning Letters Starts to Decrease

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

 

A blog entry that evaluated FDA enforcement actions in the first half of FY2016 provided data to demonstrate that the interval between GMP drug inspections and warning letters almost doubled since FY2013.  The relevant table and graph is provided below.

Continue reading

Warning Letters

FDA Sent These 13 Warning Letters for Pharma Companies | August 2016

We took a snapshot of the 13 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from failing to “maintain written records” to failing to wear “clothing appropriate to protect drug product.”

From pharmaceuticals in Brazil, India, China, and 6 US states, here they are (starting with the most recent):
Continue reading

3 Key Learnings from the PDA/FDA Joint Conference

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

OVERALL:  This is the 25th anniversary of the PDA/FDA conference and many of the presentations provided evidence of the significant progress made in research and medicine during this time.  It was fascinating to stand back for a few moments to see just how far we’ve come.  The overall conclusion I take from the two days of the conference that I attended are:

Continue reading