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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

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 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 Bernick's Registered Holsteins Minneapolis District Office Illegal Drug Residue November 13, 2012
October 01, 2012 Modesto Junior College San Francisco District Office Illegal Drug Residue Not Issued *
September 28, 2012 Healthy People CO Los Angeles District Office Unapproved and Misbranded New Drugs 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 28, 2012 Boyce, Steven W., M. D. Center for Drug Evaluation and Research Clinical Investigator 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 Altura Food, Inc. San Juan District Office Juice HACCP/CGMP for Foods/Labeling/Misbranded Not Issued *
September 27, 2012 Mid Pac Foods, Inc. San Francisco District Office Acidified Foods/CGMP Regulations/Adulterated 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 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 Texas Applied Biomedical Services Center for Biologics Evaluation and Research IRB (Institutional Review Board) Not Issued *



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