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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 Vansridge Dairy New York District Office Illegal Drug Residue 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 www.cheapcigarettes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 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 Woodland Sedgwick LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded March 09, 2016
December 29, 2015 Sorin Group Deutschland GmbH Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
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 23, 2015 Hawk Dairy Farm Cincinnati District Office Illegal Drug Residue Not Issued *
December 23, 2015 Cadila Healthcare Limited Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated 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 Ionia Pharmacy Los Angeles District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded 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 ARB Medical, LLC Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated 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 18, 2015 Fabrica Confecciones Soto, Inc. San Juan District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *



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