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.
Of course, this is part of the on-going trend of increased international inspection activity as the FDA “catches up” with the reality that 80% of all active pharmaceutical ingredients (APIs) for the US market is manufactured in either India or China. Can China learn from India?
Mr. Baker exclusively inspected Indian facilities from September 2012 through December 2014, performing 41 inspections leading to 17 Warning Letters. In January 2015, he shifted his focus to China. Anonymous industry sources say that Chinese and Indian companies have several issues, but the primary area of concern continues to be data integrity. Disturbingly, Indian companies have become much more “sophisticated” in how they hide, manipulate, and destroy manufacturing data. Hopefully, Chinese companies learn how to solve their data integrity problems (which are quality culture-related at its root), instead of learning how better to mask them.
Why has there not been a bigger public uproar about these issues? Think about it – the majority of drugs that Americans consumed are being manufactured at facilities where it is possible that data is being shredded in the middle of the night and/or their “sample testing” are rigged to pass because the “right” sample is tested.
This data has been released as part of a new infographic about FDA Warning Letters that you can see below. We’ll break down this data more in the days ahead.
Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483s, Inspector Profiles, Enforcement Analytics, and GMP Regulatory Intelligence. Contact me if you ever have questions at firstname.lastname@example.org.