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