Resources

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 12/2/2015 Adapta Medical, Inc. Colorado Springs CO United States 7/30/2015 Advanced OrthoPro, Inc. Indianapolis IN United States 5/21/2014 AMAG Pharmaceuticals, Inc. Waltham MA United States 11/10/2010 Apinya B. Vutikullird, […]

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 5/23/2014 21st Century Oncology, Inc. Naples FL United States 1/22/2016 Boston Scientific Neuromodulation Corporation Valencia CA United States 10/25/2013 Bushu Pharmaceuticals Ltd. Kawagoe-shi Japan 9/17/2015 CMR Naviscan Corporation Carlsbad […]

A consent decree agreement is an agreement filed in the US courts formalizing a voluntary agreement between two parties. Here we will address consent decree agreements between FDA and several pharmaceutical companies based on repeated failures to adequately address CGMP deficiencies. It is not an action taken on the basis of a single form 483, […]

If you haven’t been to FDAzilla.com in a while, then you’ve come to the right place. If any part of your job involves preparing your company for FDA GMP inspections, let me take you on a quick tour of some tools and resources that you might find useful!  Take 4 minutes and check out these 4 […]

We see a lot of people, all throughout the world, purchasing 483s from our FDA 483s store. For example, this month, customers from Japan, Italy, China, United Kingdom, and the United States purchased 483s.  As a reminder, here are 5 features to look for in a 483. Here are the latest 30 483s purchased from us: […]

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 10/5/2015 Arthrosurface, Inc. Franklin MA United States 4/10/2015 Changzhou Sunlight Pharmaceutical Co., Ltd. Changzhou City China 8/30/2001 Chediak, Juan, M.D. Chicago IL United States 3/27/2015 Cspc Zhongnuo Pharm (shijiazhuang) […]

FDA and the EU have taken serious enforcement actions against several firms in the others geographic jurisdiction in calendar year 2016. Perhaps this flurry of my-inspectors-are-more-rigorous-than-yours type represents an unofficial test of sorts as these two agencies move to rely more on each other’s inspections.These inspections may test the limits and validity of the underlying […]

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 9/17/2015 American Dent-all Inc Glendale CA United States 9/10/2015 Bedfont Scientific, Ltd. Maidstone United Kingdom 9/17/2015 Biomatlante Vigneux De Bretagne France 11/13/2015 Boehringer Ingelheim Pharma Gmbh & Co Kg […]

Due to popular demand, we have decided to add EIRs into our store. Establishment Inspection Reports (EIRs) are an important tool in your tool belt of inspection preparation and intelligence. If you aren’t familiar with them, read our recent post on the 5 Things to Look for in an EIR. We’ve collected almost 2,000 EIRs, categorizeSimply […]

Reading through the news, here were 9articles thatwere wortha closer look. Interview with Director of Celogen Life Science: “Sun Pharma will be unstoppable if it integrates Ranbaxy well.” – Jun 11 – The Economic Times interviews Amit Rajan, director of Celogen Life Science, who discusses India’s Pharmaceutical industry and the significance of Ranbaxy’s former role in Indian Pharma. This […]