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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

2013 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
November 25, 2013 Fresh Directions Dominicana Center for Food Safety and Applied Nutrition Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
November 25, 2013 San Up S.A. Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
November 22, 2013 23andMe, Inc. Center for Devices and Radiological Health Premarket Approval/Adulterated March 25, 2014
November 22, 2013 Trokamed GmbH Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
November 22, 2013 Vendors Unlimited Corporation Kansas City District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
November 21, 2013 Raw Deal, Inc New Jersey District Office Dietary Supplement/Adulterated Not Issued *
November 21, 2013 Agnes E. Ubani, MD Center for Drug Evaluation and Research Clinical Investigator   Not Issued *
November 20, 2013 Shoney Scientific India Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
November 20, 2013 Manhattan Reproductive Medicine, PC New York District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Not Issued *
November 20, 2013 Hyperion Medical Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
November 19, 2013 Head Farms New York District Office Illegal Drug Residue Not Issued *
November 19, 2013 Sreedhar Samudrala Center for Drug Evaluation and Research Clinical Investigator Not Issued *
November 19, 2013 Sanitary Dairy Foods Inc Kansas City District Office CGMP/Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
November 19, 2013 CLEDALE Cincinnati District Office Illegal Drug Residue Not Issued *
November 18, 2013 Ka-vern Farms New York District Office Illegal Drug Residue Not Issued *
November 18, 2013 Nickels, Joseph E. Minneapolis District Office Illegal Drug Residue February 05, 2014
November 18, 2013 Andrew Kiraly New York District Office Illegal Drug Residue Not Issued *
November 18, 2013 ACPETAMAR De R.L. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
November 18, 2013 SYNECCO LTD. Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
November 18, 2013 Sprague Ranch, LLC New England District Office Illegal Drug Residue Not Issued *



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