Resources

Is part of your job to prep your company for FDA inspections? Do you spend part of your week culling through various FDA, EMA, ICH, PIC/S and EMA-related websites tracking down changes in regulations, guidelines, and concept papers? Is the FDA ORA reading room bookmarked on your browser? If so, we are excited to […]

Sometimes we get emails from people who are just starting out in the field of regulatory, quality, and compliance, asking us – what advice do we havefor new people to get onto the right path? I turned to you on LinkedIn, and these are some of my favorite responses: It basically comes down to this.., […]

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 3/15/13 Paragon Research Center San Antonio TX United States 7/7/11 Patheon Inc. Whitby Canada 4/6/12 Peptido GmbH Bexbach Germany 2/27/13 Philips Burton Franklin Park IL United States 12/18/13 PureTek […]

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, […]