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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

2012 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
October 02, 2012 Bausch & Lomb, Inc. Florida District Office New Drug/Misbranded Not Issued *
October 02, 2012 Akorn, Inc. Chicago 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 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 Pulse Health LLC Seattle District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded April 15, 2013
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 Healthy People CO Los Angeles District Office Unapproved and Misbranded New Drugs Not Issued *
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 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 Natures One Inc Center for Food Safety and Applied Nutrition Food Labeling/Misbranded 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 First Medical Source LLC Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated 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 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 Copious International, Inc Center for Devices and Radiological Health Medical Device Reporting/Misbranded April 22, 2013
September 24, 2012 Texas Applied Biomedical Services Center for Biologics Evaluation and Research IRB (Institutional Review Board) Not Issued *



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