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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2014 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
May 05, 2014 Gallagher Farms, LLC New York District Office Illegal Drug Residue Not Issued *
May 02, 2014 Grandpa's Compounding Pharmacy, Inc. San Francisco District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
May 02, 2014 Brookfield Prescription Center Inc. dba MD Custom Rx Minneapolis District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
May 01, 2014 Dr. Joel Kaplan Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 01, 2014 Sea Fex, Inc. dba Seafood Express Philadelphia District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
April 30, 2014 Ana J. Fandino Center for Drug Evaluation and Research Clinical Investigator Not Issued *
April 30, 2014 FRANZESE S.P.A. Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated Not Issued *
April 30, 2014 Caito Fisheries, Inc. San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
April 30, 2014 Blue Ridge Pharmacy and Compounding Center Atlanta District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
April 30, 2014 Michele Sewell, M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
April 28, 2014 Ruemu Birhiray Center for Drug Evaluation and Research Clinical Investigator Not Issued *
April 28, 2014 Acme Monaco Corporation New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
April 25, 2014 Gold Standard Diagnostics San Francisco District Office Quality System Regulation for Medical Devices/Adulterated Not Issued *
April 23, 2014 Cho & So, Inc. DBA Oh Bakery Philadelphia District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
April 23, 2014 GaleMed Xiamen Co., Ltd. Center for Devices and Radiological Health Medical Device Reporting/Misbranded August 13, 2014
April 23, 2014 Ip-6 International Inc. Florida District Office Unapproved and Misbranded New Drugs Not Issued *
April 23, 2014 Smokers Outlet Online Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded May 13, 2014
April 22, 2014 Mundo Natural Inc San Juan District Office Unapproved and Misbranded New Drugs Not Issued *
April 22, 2014 Charlemagnes Tree Farm Ltd dba Hudson Valley Homestead New York District Office Labeling/Misbranded Not Issued *
April 22, 2014 Americare Compounding, LLC. New York District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *



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