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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
11/27/2013 St Vincent Hosp And Hlth Care Center for Drug Evaluation and Research Institutional Review Board (IRB) Not Issued *
11/27/2013 Blue Marine Seafood Inc Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
11/27/2013 Jubilant HollisterStier, LLC Seattle District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
11/27/2013 www.snusory.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
11/27/2013 Vicrossano Inc. Center for Food Safety and Applied Nutrition CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
11/27/2013 Blossom Valley Foods Inc San Francisco District Office Acidified Foods/Emergency Permit Control/Adulterated/Misbranded Not Issued *
11/26/2013 Maple Lane Dairy, Inc. New York District Office Illegal Drug Residue Not Issued *
11/26/2013 James W. Michalek New York District Office Illegal Drug Residue Not Issued *
11/26/2013 Verona Veterinary Services, P. C. New York District Office Illegal Drug Residue Not Issued *
11/26/2013 Empacadora Diamante S.A. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
11/25/2013 Johnson Farm LLC New York District Office Illegal Drug Residue Not Issued *
11/25/2013 Wockhardt Limited Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
11/25/2013 Sharplight Technologies Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
11/25/2013 Fresh Directions Dominicana Center for Food Safety and Applied Nutrition Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 06/22/2017
11/25/2013 San Up S.A. Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
11/22/2013 Trokamed GmbH Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated 05/18/2016
11/22/2013 Vendors Unlimited Corporation Kansas City District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated 06/18/2015
11/22/2013 23andMe, Inc. Center for Devices and Radiological Health Premarket Approval/Adulterated 03/25/2014
11/21/2013 Agnes E. Ubani, MD Center for Drug Evaluation and Research Clinical Investigator   Not Issued *
11/21/2013 Raw Deal, Inc New Jersey District Office Dietary Supplement/Adulterated Not Issued *
11/20/2013 Shoney Scientific India Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
11/20/2013 Hyperion Medical Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
11/20/2013 Manhattan Reproductive Medicine, PC New York District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Not Issued *
11/19/2013 CLEDALE Cincinnati District Office Illegal Drug Residue Not Issued *
11/19/2013 Sanitary Dairy Foods Inc Kansas City District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated 02/25/2015
11/19/2013 Head Farms New York District Office Illegal Drug Residue Not Issued *
11/19/2013 Samudrala, Sreedhar Center for Drug Evaluation and Research Clinical Investigator Not Issued *
11/18/2013 Andrew Kiraly New York District Office Illegal Drug Residue Not Issued *
11/18/2013 SYNECCO LTD. Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated 04/22/2015
11/18/2013 Nickels, Joseph E. Minneapolis District Office Illegal Drug Residue 02/05/2014
11/18/2013 Ka-vern Farms New York District Office Illegal Drug Residue Not Issued *
11/18/2013 Sprague Ranch, LLC New England District Office Illegal Drug Residue Not Issued *
11/18/2013 ACPETAMAR De R.L. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
11/15/2013 Kootenai Medical Center IRB Center for Devices and Radiological Health Institutional Review Board (IRB) Not Issued *
11/14/2013 Ad-Tech Medical Instrument Corporation Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated 10/23/2014
11/14/2013 Ed Vander Woude Dairy Los Angeles District Office Illegal Drug Residue Not Issued *
11/14/2013 Mectra Labs, Inc. Center for Devices and Radiological Health Quality System Regulation for Medical Device Reporting/Adulterated/Misbranded Not Issued *
11/14/2013 Mountain Laurel Log Homes and Land, Inc. dba Kickin Mule Atlanta District Office Acidified Foods/Adulterated Not Issued *
11/14/2013 Clinical Lasers, Inc. Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
11/14/2013 Berlin Valley Farm Cincinnati District Office Illegal Drug Residue Not Issued *
11/14/2013 Cheen Houng Enterprise Co., Ltd. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated 07/21/2016
11/13/2013 David C. Kauffman Kansas City District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
11/08/2013 Northwest Veterinary Associates, Inc. New England District Office Animal Drugs/Adulterated   Not Issued *
11/07/2013 HONG NGOC PTE Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
11/07/2013 Irvington Seafood Inc. New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
11/04/2013 www.tobaccocountry.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 11/26/2014
11/01/2013 Luis Dairy San Francisco District Office Illegal Drug Residue Not Issued *
11/01/2013 Resers Fine Foods Inc Kansas City District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated   09/03/2014
10/31/2013 Elam Fisher Baltimore District Office Illegal Drug Residue Not Issued *
10/29/2013 www.fontanasmokeshop.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *

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