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 10/25/13 Glenmark Generics Limited Indore India 7/19/13 Glenmark Generics Limited Colvale Bardez India 1/31/13 GS Medical Packaging Inc Mississauga Canada 5/17/12 Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd Hangzhou China […]

PRLog – Jan. 26, 2015 – CHICAGO — Today, FDAzilla announced the launch of a new GMP resource for quality, regulatory, and compliance professionals working in the pharm, biopharma, and select medical device industries. The FDA continues to increase its focus and attention on ensuring the safety of the drug supply in the U.S. Manufacturing […]

I find the typical approach to managing massive pharma compliance projects quite fascinating, particularly when it comes to problems that require a fundamental makeover. It reminds me of a three-ring circus. In the middle ring, management immediately starts to tackle the problem by doing what it does best: establishing layers of bureaucracy. The multiple layers […]

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 11/20/12 A.I.G Technologies, Inc. Deerfield Beach FL United States 9/13/13 Actavis Pharma Manufaturing Pvt. Ltd Kancheepuram District, Tamil Nadu India 6/6/13 Agnes E. Ubani, MD Tampa FL United States […]

The GMP landscape continues to evolve quickly for drug companies. Now is a good time as any to look back at the last 12 months. What did GMP-related warning letters focus on in 2014? What kind of companies are getting hit the hardest? What did GMP-related drug recalls focus on? What about the class I […]

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 3/28/13 Sreedhar Samudrala Franklin TN United States 2/15/13 Srikem Laboratories Pvt. Ltd. Navi Mumbai India 11/8/13 Stanley Security Solutions Inc Lincoln NE United States 11/20/13 Starkey Laboratories, Inc – […]

GAIN A LARGER AUDIENCE BY WRITING FOR THE FDAZILLA BLOG Are you interested in writing for the niche target of people who want to work smarter with FDA data? From compliance to quality assurance to regulatory to financial investment decision-makers to attorneys in the drug and device industries, FDAzilla’s blog reaches thousands of professionals who think, work, […]

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 12/26/13 Prexion, Inc. San Mateo CA United States 11/6/13 Prime Herbs Corporation Sunnyvale CA United States 12/1/10 Primrose Candy Co Chicago IL United States 3/28/12 Prince Medical Ercuis France […]

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 2/12/14 Endevr, LLC St George UT United States 12/11/13 Epien Medical, Inc White Bear Lake MN United States 11/6/13 Epimed International, Inc. Johnstown NY United States 8/24/12 Eric J. […]

Over the years, we’ve written quite extensively about avoiding 483s. Here’s a summary of some of the most timeless advice and perspective. While the technologies change and the areas of FDA emphasis change quite a bit, the basics of inspections don’t change. Here’s 7 basic strategies for avoiding FDA 483s. Like the saying goes, sometimes […]