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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
September 03, 2013 Omid Nassim, M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
August 30, 2013 Elder Grove Dairy Minneapolis District Office Illegal Drug Residue October 28, 2013
August 30, 2013 Lloyd Inc. of Iowa Kansas City District Office Animal Drugs/Adulterated Not Issued *
August 30, 2013 FVS Holdings, Inc. dba. Green Valley Drugs San Francisco District Office New Drug/Misbranded Not Issued *
August 30, 2013 Lucky Fortune Cookies, Inc. Baltimore District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated March 24, 2014
August 29, 2013 Y. S. Health Corp. Chicago District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Unapproved/Misbranded Not Issued *
August 29, 2013 Sanquin Plasma Products Center for Biologics Evaluation and Research CGMP Deviations Not Issued *
August 28, 2013 Gatlinburlier, INC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded November 26, 2013
August 28, 2013 Mason City Cold Storage Company Kansas City District Office Warehouse/Insanitary Conditions/Adulterated Not Issued *
August 27, 2013 Ching Jiang Fisheries Products, Inc. Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
August 27, 2013 Rushing Waters Fisheries, LLC Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions April 28, 2014
August 27, 2013 Rocky Ford Pet Foods Denver District Office Cattle Materials Prohibited in Animal Food or Feed (CMPAF)/Adulterated April 16, 2014
August 27, 2013 Weyand Fisheries, Inc. Detroit District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
August 26, 2013 St. Shine Optical Co., Ltd. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
August 26, 2013 Bio Focus Co. Ltd. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
August 22, 2013 John Brasil Dairy San Francisco District Office New Animal Drug/Adulterated Not Issued *
August 22, 2013 Jabones Pardo S.A. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
August 22, 2013 Crist Dairy Farm Cincinnati District Office Illegal Drug Residue Not Issued *
August 22, 2013 GumRunner, LLC Center for Food Safety and Applied Nutrition New Drug/Labeling/False & Misleading Claims Not Issued *
August 21, 2013 Stewart Compounding Pharmacy Atlanta District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *



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