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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 […]

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 8/26/2015 AAIPharma Services Corporation Edison NJ United States 6/5/2015 Akorn Inc. Somerset NJ United States 12/18/2015 Barr Laboratories, Inc. (div. Of Teva) Forest VA United States 1/29/2015 Biomat USA, […]

Over the years, the FDAzilla blog has published almost 300 articles. We’ve acquired a lot of new readers since we started writing here in 2010.With these newer followers in mind, FDAzilla has assembleda list ofsomeof our most usefularticles. Toput together this collection, we considered which posts havebeen the most searched-for and viewed over time, and […]

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 1/14/2015 AAI Pharma Analytical Services St Louis Inc Affton MO United States 3/27/2012 AAIPharma Services Corp. Wilmington NC United States 4/16/2010 AAIPharma Services Corp. Wilmington NC United States 8/6/2015 […]

I asked Barb Unger a difficult question, “If you could just pick 6 483s to understand this Data Integrity problem, which 6 would you pick? And why?”  Here is her response. From Barb: As we continue to follow the data integrity story, let’s take a look at six (6) forms 483 associated with data integrity that had broad […]

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 4/16/2010 AAIPharma Services Corp. Wilmington NC United States 12/21/2015 Abc Compounding Company Inc Morrow GA United States 6/5/2015 Alere San Diego, Inc. San Diego CA United States 6/22/2012 Amgen […]

If part of your job involves preparing for inspections or analyzing FDA cGMP inspection trends, you should watch this video: — Any questions? Want to get a live demo for you or your team? Contact Ben Anderson at ben@FDAzilla.com. Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get […]