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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 […]

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 […]

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 […]

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 […]

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 […]

I thought I’d share with you a few things that we believe will impact us immensely. They impact us because they impact you. 1. FDA inspectionsareundergoing a massive change. In 2015, approximately60% of inspections will happen overseas, and this trend will likely continue. Over time, I’d expect the FDA to eventually balance inspections based on […]

Here are the featured FDA 483s for the week. You can obtain these at the FDAzilla 483s store here>> 5/1/2014 Cardinal Health 414 LLC Colton CA United States 6/17/2014 Cardinal Health 418, Inc. Aurora CO United States 6/20/2014 CareFusion 2200, Inc. Mannford OK United States 5/20/2014 CaridianBCT, Inc. Lakewood CO United States 6/25/2014 Cascade Medical […]

Yesterday was Part I. Today, we get to hear a little more from Barb on her background. What publicly available information do you depend on for your job? How do you use that information? I focus primarily on the US, EU, ICH and PIC/S. For laws, regulations and guidance the regulator specific websites publish information […]

Barbara Unger: I see four trends in drug GMP enforcement actions over the past couple of years and all reinforce FDA’s focus on patient safety and public health. The most visible trend for fiscal year 2014 warning letter enforcement actions was the focus on compounding pharmacies. These businesses received the majority of GMP warning letters […]