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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2014 Warning Letters

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
12/04/2014 Saint Mary's Medical Group, Inc. San Francisco District Office Mammography Quality Standards Not Issued *
12/04/2014 DG Farms San Francisco District Office Illegal Drug Residue Not Issued *
12/04/2014 Maquet Cardiopulmonary Ag Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated 04/04/2016
12/03/2014 Michael A Hatcher Cincinnati District Office Illegal Drug Residue Not Issued *
11/28/2014 Remington Medical, S.A. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
11/28/2014 Hyland Acres Jerseys, Ltd. Cincinnati District Office Illegal Drug Residue Not Issued *
11/26/2014 Buffalo Gills LLC Baltimore District Office Acidified Foods/Emergency Permit Control/Adulterated/Misbranded Not Issued *
11/26/2014 Stanmore Implants Worldwide Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
11/25/2014 Biotest Pharmaceuticals Corp. Office of Regulatory Affairs CGMP/Deviations/Biologics License Application (BLA) Not Issued *
11/25/2014 Taewoong Medical Co., Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated 09/18/2015
11/24/2014 Crimasa Criaderos De Mariscos S. A. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 06/01/2017
11/24/2014 Cell Vitals Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded 04/01/2015
11/24/2014 Jansen Enterprises, LLC dba HealthWorksUSA Minneapolis District Office New Drug/Labeling/Misbranded Not Issued *
11/24/2014 U S Infusion, Inc. dba Truecare Biomedix-USA Florida District Office CGMP/QSR/Medical Devices/Adulterated 11/10/2015
11/24/2014 Sociedad Guidomar Ltda Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
11/24/2014 Cau Tre Export Goods Processing Joint Stock Company Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
11/24/2014 My Lady's Manor Farm, Inc. Baltimore District Office Illegal Drug Residue Not Issued *
11/24/2014 Continental Mills/True Bliss Confections Center for Food Safety and Applied Nutrition Food Labeling/Misbranded 03/27/2015
11/21/2014 http://www.cigarettes24.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
11/21/2014 Fioravanti Custom Products DBA Essential Wholesale & Labs Seattle District Office New Drugs/Cosmetics Labeling and Marketing with Drug Claims Not Issued *
11/20/2014 Randall A. Ooms, Oomsview Holsteins New York District Office Illegal Drug Residue Not Issued *
11/20/2014 EMcision Ltd. Center for Devices and Radiological Health Medical Devices/Adulterated/Quality System Regulation (QSR) 09/14/2015
11/20/2014 Shantou Chaonan Liangying Hegao Plastic Toy Factory Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded 10/27/2015
11/20/2014 Long Island Pharmaceuticals LLC New York District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
11/20/2014 Hirsch's Dairy Farm New York District Office Illegal Drug Residue Not Issued *
11/20/2014 New Hope Fertility Center New York District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) 07/12/2016
11/20/2014 Urban Moonshine, Inc. New England District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
11/19/2014 Sherwood Food Distributors, LLC Detroit District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
11/19/2014 LifeSilver Center for Food Safety and Applied Nutrition Unapproved New Drugs/Misbranded 06/21/2017
11/19/2014 Floyd Raber Cincinnati District Office Illegal Drug Residue Not Issued *
11/19/2014 Eurotrol B. V. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated 03/17/2017
11/18/2014 Bodyhealth.com, LLC Center for Food Safety and Applied Nutrition Unapproved New Drugs/Misbranded Not Issued *
11/18/2014 Ebola-C Inc Center for Food Safety and Applied Nutrition Unapproved New Drugs/Misbranded Not Issued *
11/17/2014 Respironics California Inc Los Angeles District Office Medical Device Reporting/Misbranded Not Issued *
11/17/2014 Walnut Creek Kitchens, Inc. Cincinnati District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated   Not Issued *
11/14/2014 Hickory Smokehouse of Las Vegas, Inc. San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
11/14/2014 Zdenka d.d Center for Food Safety and Applied Nutrition Food Labeling/Misbranded Not Issued *
11/14/2014 Martin Star Dairy Philadelphia District Office Illegal Drug Residue 10/01/2015
11/14/2014 Scientific Botanicals Company, Inc. Seattle District Office CGMP/Dietary Supplement/Adulterated/Misbranded/Therapeutic Claims Not Issued *
11/14/2014 Balfego and Balfego, SL Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
11/13/2014 American Spice Trading Company Inc. Florida District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
11/13/2014 Beneva Tobacco & Beer Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 04/01/2015
11/12/2014 K.I.Z. FOODS LIMITED Center for Food Safety and Applied Nutrition CGMP/Acidified Foods/Adulterated Not Issued *
11/12/2014 Pagano's Inc. New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 09/01/2015
11/12/2014 Reuben R. Zimmerman New York District Office Illegal Drug Residue Not Issued *
11/12/2014 El-Vi Farms, LLC New York District Office Illegal Drug Residue Not Issued *
11/10/2014 Wells Pharmacy Network LLC Florida District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
11/10/2014 Good Morning Seoul Corp. Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated Not Issued *
11/07/2014 Kelly Hills Dairy Inc Kansas City District Office Illegal Drug Residue Not Issued *
11/07/2014 My Chai Inc. Seattle District Office CGMP/Acidified Foods/Adulterated Not Issued *

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