Resources

We took a snapshot of the 13 warning letters the FDA sent to pharmaceutical companies last month. Drug manufacturing violations ranged from failing to “maintain written records” to failing to wear “clothing appropriate to protect drug product.” From pharmaceuticals in Brazil, India, China, and 6 US states, here they are (starting with the most recent): […]

We’ve compiled August and September’s mostrelevant, important news foranyone concerned with Pharmaceutical Industry GMP and FDA inspections. Our top 12 picks are listed chronologically by publication date.Happy reading! July 25: After scandal, China begins vaccine inspections nationwide. — Discovery of a blackmarket vaccine ring earlier this year was the impetus for China’s nationwide campaign to inspect vaccine […]

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 1/22/2016 Amgen Manufacturing Limited Juncos PR United States 2/23/2015 Carlos Pantojas San Juan PR United States 9/25/2015 Charles River Laboratories Preclinical Services Reno NV United States 11/2/2015 Comprehensive Telemedicine […]

OVERALL:This is the 25th anniversary of the PDA/FDA conference and many of the presentations provided evidence of the significant progress made in research and medicine during this time.It was fascinating to stand back for a few moments to see just how far we’ve come.The overall conclusion I take from the two days of the conference […]

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 3/17/2014 Antonio Capone Royal Oak MI United States 10/14/2015 Applied BioPhotonics Ltd. Chupei City, Hsinchu District Taiwan (Province of China) 12/10/2015 Biogen US Corporation Research Triangle Park NC United […]

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 9/18/2015 Apnea Sciences Corporation Aliso Viejo CA United States 11/9/2015 Ascent Pharmaceuticals, Inc. Central Islip NY United States 12/14/2015 Austin […]

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 […]