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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

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
November 27, 2013 St Vincent Hosp And Hlth Care Center for Drug Evaluation and Research Institutional Review Board (IRB) Not Issued *
November 27, 2013 Blue Marine Seafood Inc Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
November 27, 2013 Jubilant HollisterStier, LLC Seattle District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
November 27, 2013 www.snusory.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
November 27, 2013 Vicrossano Inc. Center for Food Safety and Applied Nutrition CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
November 27, 2013 Blossom Valley Foods Inc San Francisco District Office Acidified Foods/Emergency Permit Control/Adulterated/Misbranded Not Issued *
November 26, 2013 Maple Lane Dairy, Inc. New York District Office Illegal Drug Residue Not Issued *
November 26, 2013 James W. Michalek New York District Office Illegal Drug Residue Not Issued *
November 26, 2013 Verona Veterinary Services, P. C. New York District Office Illegal Drug Residue Not Issued *
November 26, 2013 Empacadora Diamante S.A. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
November 25, 2013 Johnson Farm LLC New York District Office Illegal Drug Residue Not Issued *
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 May 18, 2016
November 22, 2013 Vendors Unlimited Corporation Kansas City District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated June 18, 2015
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 February 25, 2015
November 19, 2013 Head Farms New York District Office Illegal Drug Residue Not Issued *
November 19, 2013 Samudrala, Sreedhar 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 April 22, 2015
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 *
November 18, 2013 Sprague Ranch, LLC New England 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 15, 2013 Kootenai Medical Center IRB Center for Devices and Radiological Health Institutional Review Board (IRB) Not Issued *
November 14, 2013 Ad-Tech Medical Instrument Corporation Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated October 23, 2014
November 14, 2013 Ed Vander Woude Dairy Los Angeles District Office Illegal Drug Residue Not Issued *
November 14, 2013 Mectra Labs, Inc. Center for Devices and Radiological Health Quality System Regulation for Medical Device Reporting/Adulterated/Misbranded Not Issued *
November 14, 2013 Mountain Laurel Log Homes and Land, Inc. dba Kickin Mule Atlanta District Office Acidified Foods/Adulterated Not Issued *
November 14, 2013 Clinical Lasers, Inc. Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
November 14, 2013 Berlin Valley Farm Cincinnati District Office Illegal Drug Residue Not Issued *
November 14, 2013 Cheen Houng Enterprise Co., Ltd. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated July 21, 2016
November 13, 2013 David C. Kauffman Kansas City District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
November 08, 2013 Northwest Veterinary Associates, Inc. New England District Office Animal Drugs/Adulterated   Not Issued *
November 07, 2013 HONG NGOC PTE Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
November 07, 2013 Irvington Seafood Inc. New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
November 04, 2013 www.tobaccocountry.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded November 26, 2014
November 01, 2013 Luis Dairy San Francisco District Office Illegal Drug Residue Not Issued *
November 01, 2013 Resers Fine Foods Inc Kansas City District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated   September 03, 2014
October 31, 2013 Elam Fisher Baltimore District Office Illegal Drug Residue Not Issued *
October 29, 2013 www.fontanasmokeshop.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *

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