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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2013 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
December 13, 2013 G and G Peppers Detroit District Office Low Acid Canned Food Regulation/Adulterated/Insanitary Conditions Not Issued *
December 13, 2013 Pesquera Alvarez y Alvarez Ltda Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
December 13, 2013 PARAYIL FOOD PRODUCTS PVT. LTD. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
December 13, 2013 Krier Foods, Inc. Minneapolis District Office CGMP/Dietary Supplement/Adulterated/Misbranded July 18, 2014
December 12, 2013 Health Breakthrough International, LLC Seattle District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
December 12, 2013 Racer Technology Pte Ltd Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
December 12, 2013 SKINREX CO., LTD Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
December 12, 2013 Florida Fertility Institute Florida District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Not Issued *
December 12, 2013 DNO Inc Cincinnati District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
December 11, 2013 Dutch-Maid Bakery New Orleans District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
December 11, 2013 Coastal Contacts Inc. Center for Devices and Radiological Health Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded Not Issued *
December 09, 2013 Mayor Laboratories Inc Los Angeles District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
December 06, 2013 Eagle New York New Jersey District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions May 02, 2014
December 05, 2013 Osaki Suisan Co., Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
December 05, 2013 Green Planet Inc Los Angeles District Office Unapproved and Misbranded New Drugs Not Issued *
December 04, 2013 PurQuality, LLC Los Angeles District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
December 04, 2013 Himmelspach, William W. Seattle District Office Illegal Drug Residue Not Issued *
December 04, 2013 Hubbard Feeds, Inc. Detroit District Office CGMP/Medicated Feeds/Adulterated Not Issued *
December 04, 2013 Rehabtronics Inc. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
December 04, 2013 Smith Dairy Cincinnati District Office Illegal Drug Residue Not Issued *



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