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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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2012 Warning Letters

Posted on October 16, 2012

Letter Issue Date Company Name Issuing Office Subject Close Out Date
September 28, 2012 Pulse Health LLC Seattle District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded April 15, 2013
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 27, 2012 Mid Pac Foods, Inc. San Francisco District Office Acidified Foods/CGMP Regulations/Adulterated Not Issued *
September 27, 2012 Altura Food, Inc. San Juan District Office Juice HACCP/CGMP for Foods/Labeling/Misbranded Not Issued *
September 26, 2012 First Medical Source LLC Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
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 Natures One Inc Center for Food Safety and Applied Nutrition Food Labeling/Misbranded Not Issued *
September 25, 2012 Copious International, Inc Center for Devices and Radiological Health Medical Device Reporting/Misbranded April 22, 2013
September 25, 2012 V and L Dairy Seattle District Office Illegal Drug Residue Not Issued *
September 25, 2012 Kaiser Permanente - 20th Avenue Medical Center Dallas District Office Mammography Quality Standards Not Issued *
September 25, 2012 Acu International Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
September 24, 2012 Celltex Therapeutics Corporation Center for Biologics Evaluation and Research Human Cells, Tissues & Cellular Products Not Issued *
September 24, 2012 Texas Applied Biomedical Services Center for Biologics Evaluation and Research IRB (Institutional Review Board) 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) Not Issued *
September 21, 2012 Canadadrugs Center for Drug Evaluation and Research Unapproved and Misbranded New Drugs Not Issued *
September 21, 2012 Janson-Beckett Center for Food Safety and Applied Nutrition New Drug Application [NDA] Not Issued *
September 21, 2012 Andes Natural Center for Food Safety and Applied Nutrition New Drug Application [NDA] Not Issued *
September 19, 2012 Create-A-Pack Foods, Inc. Minneapolis District Office CGMP/Acidified Foods/Adulterated Not Issued *
September 19, 2012 Epimed International, Inc. New York District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *


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