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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 08, 2014 Nuvolase Inc. San Francisco District Office Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device Not Issued *
May 08, 2014 Analytical Control Systems, Inc Detroit District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 07, 2014 Sun Pharmaceutical Industries Limited - Karkhadi Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
May 06, 2014 Empresas Barsan, Inc. San Juan District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
May 06, 2014 Galil Importing Corp. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
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 05, 2014 Gallagher Farms, LLC New York District Office Illegal Drug Residue Not Issued *
May 02, 2014 Brookfield Prescription Center Inc. dba MD Custom Rx Minneapolis District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
May 02, 2014 Grandpa's Compounding Pharmacy, Inc. San Francisco District Office CGMP/Finished Pharmaceuticals/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 *
May 01, 2014 Dr. Joel Kaplan Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
April 30, 2014 Michele Sewell, M.D. Center for Drug Evaluation and Research Clinical Investigator 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 FRANZESE S.P.A. Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated Not Issued *
April 30, 2014 Ana J. Fandino 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 Ip-6 International Inc. Florida District Office Unapproved and Misbranded New Drugs Not Issued *



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