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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 16, 2014 Jack Hall Farm Cincinnati District Office Illegal Drug Residue Not Issued *
May 16, 2014 R&D Engineering Of Earlham Inc Kansas City District Office Medical Device/CGMP/Adulterated Not Issued *
May 15, 2014 Southeast Asian Packaging and Canning Limited. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
May 15, 2014 AMK Food Export (Pvt) Ltd Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated, Low Acid Canned Food Regulation/Adulterated Not Issued *
May 14, 2014 SSE Manufacturing, Inc Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
May 13, 2014 Maharaja Foods Importers Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
May 13, 2014 Fiber Foods, Incorporated Baltimore District Office Food Labeling/Adulterated/Misbranded Not Issued *
May 13, 2014 Cardiac Assist, Inc Philadelphia District Office Medical Device Reporting/Misbranded Not Issued *
May 13, 2014 Louisa Food Products Inc Kansas City District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
May 12, 2014 Veinwave Ltd Center for Devices and Radiological Health Promotion and Advertising/Misleading/Misbranded Not Issued *
May 12, 2014 Led Dental Inc Center for Devices and Radiological Health Promotion and Advertising/Misleading/Misbranded Not Issued *
May 09, 2014 Nature's Pharmacy & Compounding Center Atlanta District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
May 09, 2014 Jade & Pearl, Inc. Florida District Office Medical Device Reporting/Premarket Approval/Misbranded Not Issued *
May 08, 2014 Advanced Renal Technologies Inc Seattle District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
May 08, 2014 Analytical Control Systems, Inc Detroit District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 08, 2014 Nuvolase Inc. San Francisco District Office Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device 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 Eddies Place d/b/a Esther Kwakyewa New York 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 Empresas Barsan, Inc. San Juan District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *



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