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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 10, 2012 Garlic Rx Cincinnati District Office New Drug/Labeling/Misbranded Not Issued *
October 10, 2012 PC Tan Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
October 10, 2012 Primus Medical LLC Cincinnati District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
October 10, 2012 Balin, Martin S., MD, PhD Chicago District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) April 23, 2013
October 10, 2012 Nissei Precision Instruments (Suzhou) Co., Ltd Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
October 09, 2012 SMT-Schilling Metalltechnik GmbH Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
October 09, 2012 Country Fresh Orlando, LLC Florida District Office Labeling/False & Misleading Claims/Misbranded July 11, 2013
October 09, 2012 MEDDEV USA, INC. Dallas District Office Medical Devices/Adulterated/Quality System Regulation (QSR) Not Issued *
October 09, 2012 Medical Device Resource Corp San Francisco District Office Premarket Approval/Misbranded/Adulterated Not Issued *
October 09, 2012 Stat Rx USA Atlanta District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
October 05, 2012 Wholistic Herbs, Inc. Dallas District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
October 05, 2012 Xiantao Rayxin Medical Products Co. Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
October 05, 2012 Avon Products, Inc. (U.S. Headquarters) Center for Food Safety and Applied Nutrition New Drug/Misbranded Not Issued *
October 05, 2012 Food for Health International, LLC Denver District Office CGMP For Manufacturing, Packaging, Labeling, or Holding for Dietary Supplements/Adulterated January 13, 2014
October 05, 2012 Bioque Technology Center for Food Safety and Applied Nutrition New Drug Application [NDA] Not Issued *
October 05, 2012 Hiossen Inc. Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated November 19, 2013
October 05, 2012 Tri State Agri Services, LLC Dallas District Office CGMP for Licensed Medicated Feeds/Adulterated Not Issued *
October 04, 2012 Tropical Seafood New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
October 04, 2012 Raw Deal, Inc New Jersey District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
October 03, 2012 Millington Seafood LLC Baltimore District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions September 19, 2013



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