FAQ: “Why Do You Sell FDA 483s? Aren’t they free?”

Good question, I’m glad you asked! It’s true that the FDA releases FDA 483s on their ORA FOIA Reading Room. However, these represent only the most frequently requested 483s. In fact, if you look over the years, there are probably close to 100,000 FDA 483s sitting somewhere on an FDA server. They release only a […]

38 New Featured FDA 483s | Apr 21, 2015

Here are the featured FDA 483s for the week. You can obtain these at the FDAzilla 483s store here>> Inspection End Date Company City/Local State/Region Country 1/31/2014 AAI Pharma Analytical Services St Louis Inc Affton MO United States 4/3/2014 Aaron Industries Inc Lynwood CA United States 5/25/2011 Alpha Industries, Inc. Clearwater FL United States 5/2/2014 […]

15 New Featured FDA 483s | Apr 14, 2015

Here are the featured FDA 483s for the week. You can obtain these at the FDAzilla 483s store here>> 1/18/2013 Tomasovic, Jerry, M.D. san Antonio TX United States 6/16/2014 Topcon Medical Systems, Inc. Oakland NJ United States 5/13/2014 Topiderm Inc. North Amityville NY United States 5/8/2014 TP Orthodontic Appliance (Wuxi) Co., Ltd. Wuxi China 5/1/2014 […]

Data Integrity: The Whole Story

Now, we go deep into a serious issue that has received a lot of attention and press – data integrity. I’d venture to guess that billions of market capital has been lost because of this one issue. The crazy part is this – it’s not even close to being a new issue. As you’ll see, […]

10 New Featured FDA 483s | Apr 7, 2015

Here are the featured FDA 483s for the week. You can obtain these at the FDAzilla 483s store here>> 5/13/2014 Shiseido America Inc. East Windsor NJ United States 5/8/2014 Sopro Comeg GmbH Tuttlingen Germany 5/9/2014 SteriGear, LLC Provo UT United States 6/17/2014 Surgical Design Inc Lorton VA United States 5/30/2013 T.C. Bauer Company Chicago IL […]

New Question FDA Inspectors May Ask You at Your Next Inspection

I was intrigued by a recent conversation I had with Barbara Unger, the editor-in-chief for GMP Regulatory Intelligence. It’s becoming increasingly clear that the FDA wants to make sure you have a rigorous process to stay updated about the latest regulations and guidelines. Here’s what she had to say: Barbara Unger: Small and mid-size pharmaceutical companies […]

10 New Featured FDA 483s | Mar 31, 2015

Here are the featured FDA 483s for the week. You can obtain these at the FDAzilla 483s store here>> 5/2/2014 Oakworks Inc New Freedom PA United States 6/18/2014 Obalon Therapeutics Inc Carlsbad CA United States 6/18/2014 Oceanic Medical Products, Inc. Atchison KS United States 6/23/2014 Onemednet Corporation Seattle WA United States 6/2/2014 Particle Dynamics International […]

We Learned 5 Things from 2014 FDA and EU GMP Drug Enforcement Actions

This retrospective look at 2014 focuses on a few actions taken by regulators that have high impact to the pharmaceutical industry. It is not meant to be an all-encompassing analysis of actions taken in 2014. The actions we choose to address for 2014 are: Total FDA drug GMP warning letters were essentially flat in FY […]

10 New Featured FDA 483s | Mar 24, 2015

Here are the featured FDA 483s for the week. You can obtain these at the FDAzilla 483s store here>> 6/4/2014 Medrite Supply Inc. Walnut Creek CA United States 5/15/2014 Medtronic Vascular Galway Limited Galway Ireland 1/18/2013 Michael M. Dao, M.D. Garden Grove CA United States 5/16/2014 Micro Power Electronics, Inc. dba Electrochem Solutions, Inc Beaverton […]

10 New Featured FDA 483s | Mar 17, 2015

Here are the featured FDA 483s for the week. You can obtain these at the FDAzilla 483s store here>> 5/21/2014 Inoveon Corporation Oklahoma City OK United States 1/18/2013 Jerzy Windyga, MD, PhD Warsaw Poland 11/1/2013 Kong Teng TAN, M.D. Toronto Canada 5/10/2014 KORR Medical Technologies, Inc. Salt Lake City UT United States 6/25/2014 Life Sensing […]
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