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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

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
May 08, 2014 Analytical Control Systems, Inc Detroit District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 08, 2014 Advanced Renal Technologies Inc Seattle District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded March 02, 2016
May 07, 2014 Sun Pharmaceutical Industries Limited - Karkhadi Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
May 06, 2014 Galil Importing Corp. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions December 08, 2014
May 06, 2014 Eddies Place d/b/a Esther Kwakyewa New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
May 06, 2014 Empresas Barsan, Inc. San Juan District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions June 12, 2015
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 January 11, 2016
May 01, 2014 Dr. Joel Kaplan Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated May 05, 2015
May 01, 2014 Sea Fex, Inc. dba Seafood Express Philadelphia District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions May 19, 2015
April 30, 2014 FRANZESE S.P.A. Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated June 02, 2015
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 June 14, 2016
April 30, 2014 Sewell, Michele M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
April 30, 2014 Fandino, Ana J. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
April 28, 2014 Birhiray, Ruemu 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 November 21, 2014
April 25, 2014 Galanz Microwave Oven and Electrical Appliances Manufacturing Co. Ltd. Center for Devices and Radiological Health Medical Devices/Winchester Engineering and Analytical Center (WEAC) Not Issued *
April 25, 2014 Gold Standard Diagnostics San Francisco District Office Quality System Regulation for Medical Devices/Adulterated April 15, 2015
April 23, 2014 GaleMed Xiamen Co., Ltd. Center for Devices and Radiological Health Medical Device Reporting/Misbranded August 13, 2014
April 23, 2014 Cho & So, Inc. DBA Oh Bakery Philadelphia District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions April 22, 2016
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 Americare Compounding, LLC. New York District Office CGMP/Finished Pharmaceuticals/Adulterated February 06, 2017
April 22, 2014 River Hills Harvest dba Elderberrylife Kansas City District Office Labeling/False & Misleading/New Drug/Misbranded December 09, 2015
April 22, 2014 Mundo Natural Inc San Juan District Office Unapproved and Misbranded New Drugs November 25, 2014
April 22, 2014 Griffith Dairy Denver District Office Illegal Drug Residue December 11, 2015
April 22, 2014 Charlemagnes Tree Farm Ltd dba Hudson Valley Homestead New York District Office Labeling/Misbranded Not Issued *
April 21, 2014 Greer Laboratories Inc Office of Regulatory Affairs CGMP Deviations  Not Issued *
April 21, 2014 Labotech Microscopes India Private Limited Center for Devices and Radiological Health Medical Device Reporting/Adulterated/Misbranding July 21, 2016
April 18, 2014 Pancrazio S.P.A. Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated April 04, 2016
April 18, 2014 Iowa Select Herbs Kansas City District Office New Drug/Labeling/Misbranded/CGMP/Adulterated Not Issued *
April 18, 2014 Rogerio Lobo, M.D. Center for Drug Evaluation and Research Sponsor Not Issued *
April 17, 2014 Mar Cor Purification Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated March 26, 2015
April 17, 2014 Hahn's Old Fashioned Cake Company, Inc. New York District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/Misbranded Not Issued *
April 17, 2014 CDJ Holding, Inc., DBA Pacific BioLogic Co. San Francisco District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
April 17, 2014 Biondillo's Bakery Chicago District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/Misbranded   Not Issued *
April 16, 2014 Instituto Bioclon, S.A. de C.V. Center for Biologics Evaluation and Research CGMP Deviations August 04, 2015
April 15, 2014 Cook Vascular Inc. Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k); Promotion and Advertising/Misleading/Misbranded Not Issued *
April 11, 2014 Rongcheng Shidao Guangxin Food Co., Ltd. Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated June 20, 2014
April 11, 2014 Sanmina-SCI AB Center for Devices and Radiological Health Medical Devices/Adulterated/Quality System Regulation (QSR) August 07, 2014
April 11, 2014 SANUM-Kehlbeck GmbH & Co. KG Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
April 11, 2014 Han Yang Oriental Food Mfg Seattle District Office Food CGMP Violations Not Issued *
April 10, 2014 Montana Fish Company Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions October 20, 2014
April 10, 2014 AMKS TIME RELEASE LAB, LLC Center for Drug Evaluation and Research Sponsor/Monitor/Contract Research Organization Not Issued *
April 10, 2014 American Medical Systems, Inc. Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
April 09, 2014 Sunrise Meats, Inc. Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated/Misbranded Not Issued *
April 09, 2014 Pereira's Dairy Farm New York District Office Illegal Drug Residue Not Issued *
April 09, 2014 Boyko Foods, LLC Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions July 01, 2015

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