POSTS

Post by Michael de la Torre | May 30, 2019

Data Integrity Trends in 483s and Warning Letters: Part 3

Does the FDA cite the same data integrity keywords on warning letters as 483s? Not really.

Post by Michael de la Torre | May 24, 2019

Data Integrity Trends in 483s and Warning Letters: Part 2

Part two of this series will walk through our tagging methodologies and analysis on data integrity keyword 483 citations over the last five years.

Post by Michael de la Torre | May 16, 2019

Data Integrity Trends in 483s and Warning Letters: Part 1

Did you know that “data integrity” is the second most-cited keyword in CDER warning letters? Or that it ranks 33rd of 483 cited keywords?

Post by Michael de la Torre | April 25, 2019

Researching Combination Product Enforcement

When it comes to scanning 483 observations, can a 15-second search replace hours (or weeks) of research and still provide enough data?
Yes, and more.

Post by Michael de la Torre | April 12, 2019

CDER Enforcement Trends in Asia Pacific

CDER inspections in the Asia Pacific region are up 103% since 2013. How has that influenced enforcement actions? And what about your supply chain?

Post by Michael de la Torre | April 2, 2019

CDER Warning Letter Trends by Facility Type

Overall, global CDER warning letter issuance has skyrocketed. Here we review the trends over the last five years in regard to facility type.

Post by Michael de la Torre | February 5, 2019

The Ultimate Guide to Form FDA 483s

Post by Michael de la Torre | January 9, 2019

The FDA Furlough and FOIA Requests

Post by Michael de la Torre | December 27, 2018

33 New FDA 483s Added | December 27th 2018

In the past week, we added 33 483s to our database of 27,500+ FDA inspection documents.