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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 […]

Here are the featured FDA 483s for the week. You can obtain these at the FDAzilla 483s store here>> 5/13/2015 3D and Company LLC Cincinnati OH United States 5/11/2015 Abrams Royal Pharmacy II, LLC Plano TX United States 5/8/2015 Advanced Micro Vas II, LLC Tulsa OK United States 8/17/2015 AIAC Internantional Pharma LLC Arecibo PR […]

Here are the featured FDA 483s for the week. You can obtain these at the FDAzilla 483s store here>> 10/29/2015 Abbott Healthcare (Puerto Rico) Ltd. Barceloneta PR United States 7/23/2015 American Benchmark Machine Works, LLC Olympia WA United States 2/10/2015 American Pharmaceutical Ingredients LLC Waterford MI United States 6/22/2015 Americare Compounding, LLC. Garden City South […]

5FEATURES TO LOOK FOR IN A WARNING LETTER Warning letters are the FDA’s second level of enforcement actions after issuance of a form 483. The FDA determined that either the firm’s response to the form 483 was inadequate or the observations were serious enough to support issuance of a warning letter. Often it is possible to […]

Here are the featured FDA 483s for the week. You can obtain these at the FDAzilla 483s store here>> 1/9/2014 Ajay Gopal Seattle WA United States 5/17/2011 Ajay Gopal Seattle WA United States 3/5/2014 Arbor Bay Inc Carrollton TX United States 4/9/2015 Arstasis, Inc Fremont CA United States 9/22/2014 Better Health Lab, Inc Hackensack NJ […]