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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
05/09/2014 Jade & Pearl, Inc. Florida District Office Medical Device Reporting/Premarket Approval/Misbranded Not Issued *
05/08/2014 Advanced Renal Technologies Inc Seattle District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded 03/02/2016
05/08/2014 Nuvolase Inc. San Francisco District Office Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device Not Issued *
05/08/2014 Analytical Control Systems, Inc Detroit District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
05/07/2014 Sun Pharmaceutical Industries Limited - Karkhadi Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
05/06/2014 Empresas Barsan, Inc. San Juan District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 06/12/2015
05/06/2014 Galil Importing Corp. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 12/08/2014
05/06/2014 Eddies Place d/b/a Esther Kwakyewa New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
05/05/2014 Gallagher Farms, LLC New York District Office Illegal Drug Residue Not Issued *
05/02/2014 Brookfield Prescription Center Inc. dba MD Custom Rx Minneapolis District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded 01/11/2016
05/02/2014 Grandpa's Compounding Pharmacy, Inc. San Francisco District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
05/01/2014 Sea Fex, Inc. dba Seafood Express Philadelphia District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 05/19/2015
05/01/2014 Dr. Joel Kaplan Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated 05/05/2015
04/30/2014 Sewell, Michele M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
04/30/2014 Caito Fisheries, Inc. San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
04/30/2014 Blue Ridge Pharmacy and Compounding Center Atlanta District Office CGMP/Finished Pharmaceuticals/Adulterated 06/14/2016
04/30/2014 FRANZESE S.P.A. Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated 06/02/2015
04/30/2014 Fandino, Ana J. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
04/28/2014 Birhiray, Ruemu Center for Drug Evaluation and Research Clinical Investigator Not Issued *
04/28/2014 Acme Monaco Corporation New England District Office CGMP/QSR/Medical Devices/Adulterated 11/21/2014
04/25/2014 Gold Standard Diagnostics San Francisco District Office Quality System Regulation for Medical Devices/Adulterated 04/15/2015
04/25/2014 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 *
04/23/2014 Ip-6 International Inc. Florida District Office Unapproved and Misbranded New Drugs Not Issued *
04/23/2014 Smokers Outlet Online Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 05/13/2014
04/23/2014 Cho & So, Inc. DBA Oh Bakery Philadelphia District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions 04/22/2016
04/23/2014 GaleMed Xiamen Co., Ltd. Center for Devices and Radiological Health Medical Device Reporting/Misbranded 08/13/2014
04/22/2014 Charlemagnes Tree Farm Ltd dba Hudson Valley Homestead New York District Office Labeling/Misbranded Not Issued *
04/22/2014 Griffith Dairy Denver District Office Illegal Drug Residue 12/11/2015
04/22/2014 River Hills Harvest dba Elderberrylife Kansas City District Office Labeling/False & Misleading/New Drug/Misbranded 12/09/2015
04/22/2014 Americare Compounding, LLC. New York District Office CGMP/Finished Pharmaceuticals/Adulterated 02/06/2017
04/22/2014 Mundo Natural Inc San Juan District Office Unapproved and Misbranded New Drugs 11/25/2014
04/21/2014 Labotech Microscopes India Private Limited Center for Devices and Radiological Health Medical Device Reporting/Adulterated/Misbranding 07/21/2016
04/21/2014 Greer Laboratories Inc Office of Regulatory Affairs CGMP Deviations  Not Issued *
04/18/2014 Pancrazio S.P.A. Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated 04/04/2016
04/18/2014 Rogerio Lobo, M.D. Center for Drug Evaluation and Research Sponsor Not Issued *
04/18/2014 Iowa Select Herbs Kansas City District Office New Drug/Labeling/Misbranded/CGMP/Adulterated Not Issued *
04/17/2014 CDJ Holding, Inc., DBA Pacific BioLogic Co. San Francisco District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
04/17/2014 Hahn's Old Fashioned Cake Company, Inc. New York District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/Misbranded Not Issued *
04/17/2014 Biondillo's Bakery Chicago District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/Misbranded   Not Issued *
04/17/2014 Mar Cor Purification Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated 03/26/2015
04/16/2014 Instituto Bioclon, S.A. de C.V. Center for Biologics Evaluation and Research CGMP Deviations 08/04/2015
04/15/2014 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 *
04/11/2014 Rongcheng Shidao Guangxin Food Co., Ltd. Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated 06/20/2014
04/11/2014 SANUM-Kehlbeck GmbH & Co. KG Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
04/11/2014 Sanmina-SCI AB Center for Devices and Radiological Health Medical Devices/Adulterated/Quality System Regulation (QSR) 08/07/2014
04/11/2014 Han Yang Oriental Food Mfg Seattle District Office Food CGMP Violations Not Issued *
04/10/2014 American Medical Systems, Inc. Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated 08/25/2017
04/10/2014 Montana Fish Company Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 10/20/2014
04/10/2014 AMKS TIME RELEASE LAB, LLC Center for Drug Evaluation and Research Sponsor/Monitor/Contract Research Organization Not Issued *
04/09/2014 Boyko Foods, LLC Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 07/01/2015

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