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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2015 Warning Letters

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
December 31, 2015 Zhejiang Hisun Pharmaceutical Co., Ltd. Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
December 31, 2015 cigarettes-cheaper.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
December 31, 2015 www.ciga7.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
December 30, 2015 Irvine Stem Cell Treatment Center Center for Biologics Evaluation and Research CGMP/Deviations/Biologics License Application (BLA) Not Issued *
December 30, 2015 Bennett's Inc New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
December 30, 2015 Vansridge Dairy New York District Office Illegal Drug Residue Not Issued *
December 30, 2015 Malata African & Caribbean Market New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
December 30, 2015 www.cheapcigarettes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
December 30, 2015 Woodland Sedgwick LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded March 09, 2016
December 29, 2015 Edo Sushi Express New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions April 25, 2016
December 29, 2015 Legacy Ranch #2 San Francisco District Office Illegal Drug Residue Not Issued *
December 29, 2015 Sorin Group Deutschland GmbH Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
December 23, 2015 Cadila Healthcare Limited Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
December 23, 2015 Hawk Dairy Farm Cincinnati District Office Illegal Drug Residue Not Issued *
December 22, 2015 Oculo-Plastik, Inc. Center for Devices and Radiological Health CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
December 22, 2015 Ionia Pharmacy Los Angeles District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
December 22, 2015 SonicLife.com, LLC Seattle District Office Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
December 22, 2015 ARB Medical, LLC Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
December 22, 2015 Uoya Inc. dba Shintoku, Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
December 22, 2015 Flying Food Group, LLC. Los Angeles District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated   Not Issued *
December 21, 2015 TFS Manufacturing Pty Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
December 18, 2015 Moringa Nativa San Juan District Office New Drug/Labeling/Misbranded August 03, 2016
December 18, 2015 PM Resources, Inc. dba Virbac Animal Health, Inc. Kansas City District Office CGMP/Animal Drug/Adulterated   December 15, 2016
December 18, 2015 Spoonamore Drug Co Inc Cincinnati District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
December 18, 2015 Fabrica Confecciones Soto, Inc. San Juan District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
December 18, 2015 Tri-Med, Inc. dba Advanced Care Infusion-Shelby Detroit District Office Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
December 18, 2015 Nutrafill, LLC Atlanta District Office CGMP/Dietary Supplement/Adulterated Not Issued *
December 17, 2015 Advantage Biosciences Los Angeles District Office New Animal Drug/Adulterated Not Issued *
December 17, 2015 Sun Pharmaceutical Industries Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
December 16, 2015 Leaf Only LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
December 16, 2015 Gregory J.Tracey, M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
December 15, 2015 Chan Yat Hing Medicine Factory Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
December 15, 2015 Improva Herbal Products Center for Food Safety and Applied Nutrition Acidified Foods/Emergency Permit Control/Adulterated Not Issued *
December 11, 2015 Elite Massagers, LLC. Dallas District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
December 11, 2015 Sunrise Noodle Corp. Baltimore District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
December 11, 2015 Montana Compounding Pharmacy Seattle District Office Compounding Pharmacy/Adulteration/Misbranding Not Issued *
December 11, 2015 The One Minute Miracle Inc Florida District Office New Drug/Labeling/Misbranded Not Issued *
December 10, 2015 Agape III Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
December 10, 2015 Target Agriculture Center for Food Safety and Applied Nutrition Juice HACCP/Adulterated/Insanitary Conditions July 28, 2016
December 10, 2015 Dherbs Health Emporium Inc. Los Angeles District Office Unapproved New Drugs/Misbranded Not Issued *
December 10, 2015 Miracle in the Green Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *
December 10, 2015 www.cigarcap.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded March 09, 2016
December 10, 2015 TobaccoTrain.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded March 14, 2016
December 10, 2015 Pacific Tuna Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions February 21, 2017
December 10, 2015 Perfect Water and Essentials LLC, dba Aquagen International Denver District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated August 19, 2016
December 09, 2015 San Francisco Chocolate Factory, Limited Liability Corporate Los Angeles District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
December 09, 2015 LAR MFG., LLC Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
December 09, 2015 JGT Tobacco Company, Inc. / Cousins Distributing, Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
December 09, 2015 African Spirit Tobacco Limited Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
December 09, 2015 Chaya Herbal Food Inc San Juan District Office Unapproved New Drugs/Misbranded Not Issued *

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