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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2012 Warning Letters

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
10/04/2012 Tropical Seafood New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
10/03/2012 Millington Seafood LLC Baltimore District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 09/19/2013
10/02/2012 Bausch & Lomb, Inc. Florida District Office New Drug/Misbranded Not Issued *
10/02/2012 AHN International Inc DBA Amazing Herbs Nutraceuticals Atlanta District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
10/02/2012 Akorn, Inc. Chicago District Office New Drug/Misbranded 10/24/2014
10/01/2012 Modesto Junior College San Francisco District Office Illegal Drug Residue Not Issued *
10/01/2012 Bernick's Registered Holsteins Minneapolis District Office Illegal Drug Residue 11/13/2012
09/28/2012 Healthy People CO Los Angeles District Office Unapproved and Misbranded New Drugs Not Issued *
09/28/2012 Boyce, Steven W., M. D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
09/28/2012 James G. Cole, Inc. dba Maxam Nutraceutics Seattle District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
09/28/2012 Pulse Health LLC Seattle District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded 04/15/2013
09/27/2012 Applied Polymer Systems, Inc. d/b/a APS Pharmaco New York District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
09/27/2012 Altura Food, Inc. San Juan District Office Juice HACCP/CGMP for Foods/Labeling/Misbranded 04/01/2015
09/27/2012 Mid Pac Foods, Inc. San Francisco District Office Acidified Foods/Adulterated Not Issued *
09/26/2012 Natures One Inc Center for Food Safety and Applied Nutrition Food Labeling/Misbranded 02/03/2016
09/26/2012 Lime Essentials Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
09/26/2012 First Medical Source LLC Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated 08/15/2017
09/25/2012 Copious International, Inc Center for Devices and Radiological Health Medical Device Reporting/Misbranded 04/22/2013
09/25/2012 Acu International Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
09/25/2012 Kaiser Permanente - 20th Avenue Medical Center Dallas District Office Mammography Quality Standards Not Issued *
09/25/2012 V and L Dairy Seattle District Office Illegal Drug Residue Not Issued *
09/24/2012 Texas Applied Biomedical Services Center for Biologics Evaluation and Research Institutional Review Board (IRB) Not Issued *
09/24/2012 Celltex Therapeutics Corporation Center for Biologics Evaluation and Research Human Cells, Tissues & Cellular Products Not Issued *
09/21/2012 Janson-Beckett Center for Food Safety and Applied Nutrition New Drug Application [NDA] Not Issued *
09/21/2012 Sunset Dairy Philadelphia District Office Illegal Drug Residue Not Issued *
09/21/2012 Memorial Hospital Of South Bend, IRB Center for Drug Evaluation and Research Institutional Review Board (IRB) 04/28/2014
09/21/2012 Andes Natural Center for Food Safety and Applied Nutrition New Drug Application [NDA] Not Issued *
09/21/2012 Canadadrugs Center for Drug Evaluation and Research Unapproved and Misbranded New Drugs Not Issued *
09/19/2012 Southwind Foods LLC dba Great American Seafood Imports Co. Los Angeles District Office Labeling/Misbranded Not Issued *
09/19/2012 Zimmer Manufacturing B.V. San Juan District Office CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation Not Issued *
09/19/2012 Epimed International, Inc. New York District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
09/19/2012 Create-A-Pack Foods, Inc. Minneapolis District Office CGMP/Acidified Foods/Adulterated 05/28/2015
09/18/2012 Hopkins, E Frank Co., Inc. Philadelphia District Office CGMP for Foods/Adulterated 03/19/2013
09/18/2012 Grindstone Neck of Maine, LLC New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 10/28/2014
09/18/2012 EyeScience Labs, L.L.C. Cincinnati District Office Promotional Claims False & Misleading/New Drugs Not Issued *
09/18/2012 Sun Boricua, Inc. San Juan District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 06/07/2013
09/18/2012 Pronet/Eyal Bar Oz Center for Drug Evaluation and Research Unapproved and Misbranded New Drugs Not Issued *
09/18/2012 Fayus, Inc. dba Yusol International Foods San Francisco District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
09/18/2012 Arkadiy Kisin/White Forest Solutions Center for Drug Evaluation and Research Unapproved and Misbranded New Drugs Not Issued *
09/14/2012 Nunes Brothers Dairy Seattle District Office Illegal Drug Residue Not Issued *
09/14/2012 EMG Manufacturing Co., Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Device Reporting/Adulterated/Misbranded Not Issued *
09/14/2012 www.cigarettes-com.net Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/14/2012 Oregon Aesthetic Technologies, Inc. Seattle District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
09/13/2012 Hospital Bella Vista San Juan District Office Mammography Quality Standards Not Issued *
09/13/2012 Nick & Katie's, Inc New Orleans District Office Low Acid Canned Food Regulation/Adulterated 12/10/2013
09/13/2012 Greens Wholesale Distributors, Inc. New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
09/13/2012 Archie Domina Farm New England District Office Illegal Drug Residue Not Issued *
09/12/2012 Lin-Ro Farms Philadelphia District Office Illegal Drug Residue 03/05/2013
09/12/2012 Winter Gardens Quality Foods, Inc. Philadelphia District Office Seafood HACCP/CGMP for Foods/Adulterated 02/28/2013
09/12/2012 DMC Medical Technology & Manufacturing Co., Ltd. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *

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