Resources

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 […]

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 7/17/2015 Aretech, LLC Ashburn VA United States 5/28/2015 Catalent Belgium SA Brussels Belgium 8/11/2015 Electromedical Technologies, LLC Scottsdale AZ United States 7/24/2015 Glenmark Pharmaceuticals Ltd Indore India 4/10/2014 Innolatex […]

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 8/12/2015 Alexion Pharmaceuticals, Inc. Smithfield RI United States 7/31/2015 Alkem Laboratories Limited Solan, Himachal Pradesh India 4/3/2014 Amsino Medical (Shanghai) Co., Ltd. Shanghai China 8/11/2015 ARB Medical, LLC Minnetonka […]

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 4/21/2015 Advanced Back Technologies, Inc. Hauppauge NY United States 5/18/2015 Ajinomoto Althea, Inc. San Diego CA United States 4/3/2014 Arkray Shanghai, Ltd. Shanghaishi China 1/23/2015 Bernard A Michlin, MD […]

As we’ve written extensively about the infamous FDA 483 here at FDAzilla, we’ve decided to make it easier for you. Here, we’ve created a centralized list of the best resources to go from Joe to Pro on understanding FDA 483s. FDA 483 Articles & Resources: The New FDA GMP Inspection Model. A primer on the […]

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 6/12/2013 C.I. Antillana S.A. Cartagena Colombia 4/9/2014 Calkini Shirt Comapny S.A. de C.V. Campeche Mexico 8/27/2013 Cheese Factory Eyssen B.V. Oosthuizen Netherlands 7/16/2015 Emergent Respiratory, LLC Carlsbad CA United […]

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 7/3/2015 Alfa Wassermann S.p.A. Alanno Italy 6/16/2015 Biocon Limited Bangalore India 7/9/2015 BIOLYTICAL LABORATORIES INC. Richmond Canada 9/26/2007 Hassman, Howard, DO Clementon NJ United States 4/15/2015 High Spot Industrial […]

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 3/4/2015 Atlantic Horizon International, Inc. Beacon NY United States 3/12/2014 C-Care, LLC Linthicum Heights MD United States 4/15/2015 High Spot Industrial Company, Ltd. Taichung City Taiwan (Province of China) […]

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 3/6/2015 Advance Pharmaceutical Inc Holtsville NY United States 3/3/2015 Affinity Medical Technologies LLC Costa Mesa CA United States 8/3/2015 Diasol Inc. San Fernando CA United States 4/10/2014 DiaSorin Ireland […]

Regulatory agencies have cited deficiencies in GMP data integrity and data management for at least the past 15 years. Yet it appears that the industry as a whole has made limited progress in self-identifying and remediating these deficiencies. Regulators continue to identify the same set of shortcomings including, but not limited to: shared passwords, lack of […]