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Resources

12 New Featured FDA 483s | February 23, 2016

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 […]

12 New Featured FDA 483s | February 16, 2016

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) […]

12 New Featured FDA 483s | February 9, 2016

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 […]

Data Integrity and Enforcement Actions

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 […]

12 New Featured FDA 483s | February 2, 2016

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 3/27/2014 3M Unitek Corporation Monrovia CA United States 8/3/2015 Advanced Vision Science Inc Goleta CA United States 8/21/2015 Alliance Medical Products, Inc. Irvine CA United States 7/17/2015 Designs For […]

12 New Featured FDA 483s | January 26, 2016

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 8/3/2015 Advanced Vision Science Inc Goleta CA United States 6/19/2015 Baxter Healthcare Corp. Round Lake IL United States 3/13/2015 Bell-More Laboratories Inc Hampstead MD United States 3/12/2015 C. B. […]

56 New Featured FDA 483s | January 12, 2016

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 12/15/2014 3M Healthcare Business Saint Paul MN United States 10/27/2014 Acupac Packaging Inc Mahwah NJ United States 9/13/2010 American National Red Cross (The) San Jose CA United States 9/24/2010 […]

44 New Featured FDA 483s | January 5, 2016

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 11/21/2014 Accra Pac dba KIK Custom Products Elkhart IN United States 9/17/2010 Akorn, Inc. Decatur IL United States 6/30/2009 Akorn, Inc. Decatur IL United States 8/9/2010 American National Red […]

44 New Featured FDA 483s | December 29, 2015

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 6/30/2009 Akorn, Inc. Decatur IL United States 9/17/2010 Akorn, Inc. Decatur IL United States 6/23/2008 Amer. National Red Cross-Greater Chesapeake & Potomac Reg. Baltimore MD United States 8/13/2010 American […]

44 New Featured FDA 483s | December 22, 2015

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 11/4/2014 ABCO Laboratories, Inc. Fairfield CA United States 10/17/2014 Actavis Salt Lake City UT United States 6/16/2010 American National Red Cross National Testing Lab Detroit MI United States 12/20/2002 […]
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