tony

/Tony Chen

About Tony Chen

Tony Chen is Chairman and Co-Founder of FDAzilla, and served as Founding CEO from 2010 to 2017.
5 03, 2018

Is AI Coming to FDA Inspection Management?

By | 2018-03-05T17:36:23+00:00 March 5th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement Trends, FDA-Regulated Industry, FDAzilla, Food, Medical Devices|

About 3 months ago, I decided to take a deeper dive into Artificial Intelligence (AI). I've previously written about why and how I'm going to do so, and even coded my first neural network. While AI has been overhyped in the media, it does represent a game-changing technology that will make its way into every industry. As such, how will [...]

7 02, 2018

20,000 FDA Warning Letters

By | 2018-02-08T14:16:28+00:00 February 7th, 2018|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Warning Letters, FDA-Regulated Industry, FDAzilla, Food, Medical Devices|

Here at FDAzilla, we’re excited to report that we have just collected our 20,000th FDA Warning Letter, going back to 2000, all completely searchable in our database.  As you may know, the FDA automatically archives warning letters older than 5 years (and just did so with their 2012 collection last month).  Yes it’s true:  arguably, the older the warning letter, the [...]

19 10, 2017

Introducing FDAzilla’s New CEO

By | 2017-11-06T09:49:22+00:00 October 19th, 2017|FDAzilla|

I'm thrilled to announce that Michael de la Torre is FDAzilla's new CEO, effective October 19, 2017.  He comes to us after an already-amazing run in executive roles at several companies - leading large teams, collaborating with customers, and expertly scaling businesses. Feel free to connect with him at michael@FDAzilla.com or on LinkedIn. Read the press release here. I will step down from all my CEO duties, though you will [...]

18 10, 2017

FDA Sent These 5 Warning Letters for Pharma Companies | September 2017

By | 2017-11-27T11:16:55+00:00 October 18th, 2017|Biopharma / Pharma, FDA, FDA Enforcement News, FDA Warning Letters|

We took a snapshot of the 5 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from sites failing to establish adequate quality control to failing to label products to bear adequate directions for use. From pharmaceuticals in China, New Mexico, and more, here they are (starting with the most recent): […]

18 10, 2017

PRESS RELEASE – FDAzilla Announces New CEO

By | 2017-10-18T05:43:30+00:00 October 18th, 2017|FDAzilla|

CHICAGO, IL – October 18, 2017 FDAzilla, the leading software platform for GMP intelligence and analytics, is delighted to announce the appointment of Michael de la Torre as its new CEO, effective October 19, 2017. FDAzilla is a vital tool for FDA-regulated industries such as Pharmaceuticals, Medical Devices, CMOs, and Food Manufacturers that need insights and benchmarks on FDA inspections [...]

20 09, 2017

FDA Sent These 11 Warning Letters for Pharma Companies | August 2017

By | 2018-02-01T11:34:07+00:00 September 20th, 2017|Biopharma / Pharma, FDA, FDA Warning Letters, quality assurance|

We took a snapshot of the 11 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from failing to keep drug product infestation free to failing to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the proper education, training, and experience. From pharmaceuticals in China, Georgia, [...]