tony

/Tony Chen

About Tony Chen

Tony Chen is Chairman and Co-Founder of FDAzilla, and served as Founding CEO from 2010 to 2017.

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 [...]

Assessing Your Readiness State for FSMA: Stabilize, Then Benchmark

Assessing Your Readiness State for FSMA: Stabilize, Then Benchmark I find that the FSMA readiness of major food brands and CPGs runs the gamut from “scrambling” to “got it covered” — and everywhere in between. Smaller companies have been given more time to prepare by the FDA. Larger companies have considerably less runway to get ready. […]

By | 2017-06-20T13:40:22+00:00 March 13th, 2017|FDAzilla, quality assurance|

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): […]

By | 2017-05-16T14:53:15+00:00 February 22nd, 2017|cGMP Quality Assurance and FDA 483s, FDA, FDAzilla|

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): […]

By | 2017-05-16T14:55:43+00:00 January 26th, 2017|cGMP Quality Assurance and FDA 483s, FDA, FDAzilla|

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): […]

By | 2017-05-16T14:57:58+00:00 December 28th, 2016|cGMP Quality Assurance and FDA 483s, FDA, FDAzilla|

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): […]

By | 2017-05-16T15:01:09+00:00 November 30th, 2016|cGMP Quality Assurance and FDA 483s, FDA, FDAzilla|

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. […]