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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 1/8/2014 Aaren Scientific Inc. Ontario CA United States 6/12/2014 Akorn India PVT Paonta Sahib, Simour India 3/15/2013 ALPINION MEDICAL SYSTEMS CO. LTD Seoul Korea, Republic Of (South) 2/22/2013 […]

CHICAGO, IL –May 14, 2015 Today, FDAzilla unveiled Enforcement Analytics, a ground-breaking data analytics tool that gives industry greater insights into FDA enforcement actions and inspection activity. For the first time in the industry, data on FDA inspections, FDA inspectors, Form 483s, manufacturing sites regulated by the FDA, and FDA warning letters are all linked […]

What do you think about this infographic? Have ideas for future infographics? Post a comment below or email tony@fdazilla.com. ABOUT FDAZILLA FDAzilla offers a variety of services to help you work smarter with FDA data, particularly in the areas of inspection preparation and regulatory intelligence. Reports & Documents 483s – the largest searchable library of 483s anywhere. […]

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 12/5/2013 Abbott Point of Care Canada Limited Nepean Canada 7/22/2014 Amylin Ohio LLC West Chester OH United States 7/4/2013 ANJI ZHENGBANG MEDICAL INSTRUMENT CO, LTD Anji China 7/1/2014 […]

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 […]

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 […]

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 […]

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, […]

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 […]

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 […]