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The FR announced availability of the long awaited 10-page FDA draft Guidance on Data Integrity and Compliance with CGMP for comment.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. […]

Here are the featured FDA 483s for the week. You can obtain these at the FDAzilla 483s store here>> 6/11/2015 86 Harriet Ave Corporation DBA General Devices Ridgefield NJ United States 1/20/2015 Abbey Color, Inc. Philadelphia PA United States 12/16/2014 Adh Health Products Inc Congers NY United States 5/26/2015 Air Liquide Healthcare America Corporation Plumsteadville […]

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by Barbara Unger, FDAzilla GMP Quality Expert INDIA | IMPORT ALERT 66-40 and Association with Warning Letters Regarding These Sites | Detention Without Physical Examination of Drugs from Firms Which Have Not Met Drug GMPs  In this post, I consider the active import alerts in the “66-40” category currently posted on the FDA website for firms located in […]

Here are the featured FDA 483s for the week. You can obtain these at the FDAzilla 483s store here>> 8/11/2015 Abbott Laboratories Abbott Park IL United States 8/15/2013 Abbott Laboratories Abbott Park IL United States 3/7/2014 Acme Monaco Corporation New Britain CT United States 3/9/2011 AdvancePierre Foods, Inc. Amherst OH United States 1/14/2015 Airgas USA, […]

Here are the featured FDA 483s for the week. You can obtain these at the FDAzilla 483s store here>> 7/8/2014 Advanced Nutritional Technology Inc. Dublin CA United States 5/1/2015 Afton Scientific LLC Charlottesville VA United States 1/28/2015 Alaska Regional Hospital Irb Anchorage AK United States 6/18/2015 Albuquerque Eye Prosthetics, Inc. Albuquerque NM United States 6/28/2013 […]

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 8/17/2015 BIT Group USA, Inc. San Diego CA United States 9/18/2014 Charles D. Lopez, M.D. Portland OR United States 1/30/2015 Frances A. Collichio, MD Chapel Hill NC United States […]

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 5/14/2015 AG Essence, Inc. Richmond VA United States 1/22/2015 Canfield Scientific, Inc. Fairfield NJ United States 5/30/2014 Dana E. Rathkopf , M.D. New York NY United States 3/22/2013 Grace […]

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 8/7/2015 Cipla Limited Pithampur, District Dhar India 4/9/2015 CORENTEC CO., LTD Seobuk-gu, Cheonan-si Korea (the Republic of) 4/23/2015 G.C. Hanford Manufacturing Company Syracuse NY United States 7/24/2015 Glenmark Pharmaceuticals […]