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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 […]

Here are the featured FDA 483s for the week. You can obtain these at the FDAzilla 483s store here>> 10/31/2014 Aftab A. Naz, M.D. Madera CA United States 7/12/2013 Agilux Laboratories Worcester MA United States 3/20/2015 Ajanta Pharma Ltd. Aurangabad India 9/6/2012 Ajanta Pharma Ltd. Aurangabad India 5/21/2015 Alexza Pharmaceuticals, Inc. Mountain View CA United […]

Here are the featured FDA 483s for the week. You can obtain these at the FDAzilla 483s store here>> 3/27/2015 Aarti Industries Limited Palghar India 3/4/2015 Aesculap Implant Systems LLC Breinigsville PA United States 12/12/2013 Alexian Brothers Hospital Network IRB Arlington Heights IL United States 9/26/2014 Alexion Pharmaceuticals, Inc. Cheshire CT United States 6/30/2015 AMCO […]

Here are the featured FDA 483s for the week. You can obtain these at the FDAzilla 483s store here>> 3/5/2014 Acino Products, LLC Hamilton NJ United States 4/5/2011 ACS Dobfar Info SA CH-7748 Campascio Switzerland 4/13/2015 AG Industries LLC Saint Louis MO United States 4/10/2015 Allesee Orthodontic Appliances, Inc. Sturtevant WI United States 4/10/2014 Amarc […]

Here are the featured FDA 483s for the week. You can obtain these at the FDAzilla 483s store here>> 3/10/2015 7 OAKS PHARMACEUTICAL CORPORATION Easley SC United States 11/6/2014 Abunda Life Church of Body, Mind, and Spirit Inc. Asbury Park NJ United States 11/29/2012 ACS Dobfar S.p.A. (ACSD #6) Anagni, Frosinone Italy 12/11/2014 Admedes Schuessler […]

Here are the featured FDA 483s for the week. You can obtain these at the FDAzilla 483s store here>> 3/14/2014 3T Medical Systems, LLC Livonia MI United States 10/9/2015 Abbvie SRL Campoverde di Aprilia, Italy 12/16/2010 ACS Dobfar S.p.A. #4 Vimercate Italy 5/13/2010 ACS Dobfar s.p.a. (Plant #1) Tribiano Italy 7/4/2013 ACS Dobfar s.p.a. (Plant […]

The FR announced availability of the long awaited 10-page FDA draft Guidance on Data Integrity and Compliance with CGMP for comment. I include links to the MHRA guidance HERE and the draft WHO guidance HERE for comparison. The guidance is structured in a Q&A format with a total of 18 questions. This guidance focuses heavily on identifying and citing […]

Here are the featured FDA 483s for the week. You can obtain these at the FDAzilla 483s store here>> 10/9/2015 Abbvie SRL Campoverde di Aprilia, Italy 4/16/2014 Advanced Renal Technologies Inc Bellevue WA United States 3/31/2014 Advanced Renal Technologies Inc Bellevue WA United States 3/19/2014 Airgas USA, LLC. Lansing MI United States 6/11/2015 AlloSource, Inc. […]