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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
November 25, 2013 Wockhardt Limited Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
November 25, 2013 Sharplight Technologies Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
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 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 22, 2013 23andMe, Inc. Center for Devices and Radiological Health Premarket Approval/Adulterated March 25, 2014
November 21, 2013 Agnes E. Ubani, MD Center for Drug Evaluation and Research Clinical Investigator   Not Issued *
November 21, 2013 Raw Deal, Inc New Jersey District Office Dietary Supplement/Adulterated 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 Hyperion Medical 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 19, 2013 CLEDALE Cincinnati District Office Illegal Drug Residue 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 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 18, 2013 Andrew Kiraly New York District Office Illegal Drug Residue 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 Nickels, Joseph E. Minneapolis District Office Illegal Drug Residue February 05, 2014
November 18, 2013 Ka-vern Farms New York District Office Illegal Drug Residue Not Issued *



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