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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2008 Warning Letters

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Warning Letters issued in 2008

 

* Not issued: A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.

* N/A: Not applicable, the Warning Letter was issued prior to September 1, 2009.

Read more about warning and close-out letters

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
12/30/2008 Kidron Auction Inc. [ARCHIVED] Cincinnati District Office Illegal Drug Residue N/A *
12/30/2008 Dongkuk Techco Rubber Ind. Sdn Bhd [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Adulterated N/A *
12/24/2008 Aunt Kitty's Foods, Inc. [ARCHIVED] New Jersey District Office Food Labeling Misbranded N/A *
12/24/2008 Stoney Acres Calves [ARCHIVED] Detroit District Office Illegal Drug Residue N/A *
12/22/2008 Troyer, Todd [ARCHIVED] Cincinnati District Office Illegal Drug Residue N/A *
12/22/2008 Newman's Own Organics Center for Food Safety and Applied Nutrition N/A *
12/22/2008 Columbia Presbyterian Medical Center [ARCHIVED] New York District Office Deviation/Adulterated N/A *
12/22/2008 Newman's Own Organics [ARCHIVED] Center for Food Safety and Applied Nutrition Federal Food, Drug and Cosmetic Act/Misbranded N/A *
12/22/2008 I-Flow Corporation [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated N/A *
12/16/2008 Ocean Beauty Seafoods, Inc. [ARCHIVED] Seattle District Office Seafood HACCP N/A *
12/16/2008 Civic Center Pharmacy [ARCHIVED] Los Angeles District Office New Drug, Unapproved N/A *
12/15/2008 Craig General Hospital [ARCHIVED] Dallas District Office Deviation from Good Manufacturing Practice N/A *
12/10/2008 High Tide Seafoods, Inc. [ARCHIVED] Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
12/10/2008 Coca-Cola Company (The) [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded N/A *
12/10/2008 Virbac Inc. [ARCHIVED] Kansas City District Office CGMP For Manufacturing, Packing, Storage or Installation/Adulterated/Misbranded N/A *
12/08/2008 RGI Medical Manufacturing, Inc. [ARCHIVED] Florida District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
12/05/2008 Pneumex, Incorporated [ARCHIVED] Seattle District Office Premarket Approval/Misbranded/Adulterated N/A *
12/05/2008 Douglas Bennett Farm [ARCHIVED] New England District Office Illegal Drug Residue N/A *
12/04/2008 Haemonetics Corporation [ARCHIVED] Chicago District Office CGMP/QSR/Medical Devices/Adulterated N/A *
12/04/2008 Carib Supply of St. Croix, Inc. [ARCHIVED] San Juan District Office CGMP Manufacture, Processing, Packing or Holding of Human Drugs/Adulterated N/A *
12/03/2008 Kids Company Ltd Yugengaisha Kids [ARCHIVED] Center for Devices and Radiological Health Device/Lacks Approved Premarket Application/Adulterated/Misbranded N/A *
12/01/2008 Vital Signs, Inc. [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated N/A *
12/01/2008 Perich, Larry M [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
11/26/2008 B & C Calves/Livestock [ARCHIVED] Philadelphia District Office Illegal Drug Residue N/A *
11/25/2008 Lett Us One Corporation [ARCHIVED] San Juan District Office CGMP Manufacturing, Packing, or Holding Human Food/Adulterated N/A *
11/24/2008 Gonzalez Dairy, LLC [ARCHIVED] Denver District Office Illegal Drug Residue N/A *
11/24/2008 PDS Manufacturing, Inc. [ARCHIVED] Dallas District Office CGMP/QSR/Medical Devices/Adulterated N/A *
11/20/2008 Contract Medical Manufacturing [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated N/A *
11/19/2008 Bernhard's Bakery, Inc. [ARCHIVED] Cincinnati District Office CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated N/A *
11/19/2008 Goosefoot Acres, Inc. [ARCHIVED] Cincinnati District Office Labeling/False & Misleading Claims/New Drug/Misbranded N/A *
11/18/2008 Jeffrey Steinberg MD Inc., d/b/a The Fertility Institutes [ARCHIVED] Los Angeles District Office Human Cells, Tissues & Cellular Products N/A *
11/18/2008 Surgical Implant Generation Network [ARCHIVED] Seattle District Office CGMP for Medical Devices/QS/Adulterated N/A *
11/18/2008 RHG & Company, Inc., dba Vital Nutrients [ARCHIVED] New England District Office New Drug/Labeling/False & Misleading Claims/Misbranded N/A *
11/17/2008 Dabruzzi's Italian Foods, Inc. [ARCHIVED] Minneapolis District Office Food Labeling/False & Misleading/Misbranded N/A *
11/14/2008 Eagle Parts and Products [ARCHIVED] Atlanta District Office CGMP/QSR/Medical Devices/Adulterated N/A *
11/13/2008 Artisan Specialty Foods [ARCHIVED] Chicago District Office Seafood HACCP N/A *
11/13/2008 Rezai, Ali R, M.D [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
11/13/2008 Saudek, Christopher D. MD [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
11/13/2008 G.N.Y. Filet Fish Co., Inc. [ARCHIVED] New York District Office Seafood HACCP/GMP for Foods/Adulterated N/A *
11/12/2008 John M. Mellott Farm [ARCHIVED] Philadelphia District Office Illegal Drug Residue N/A *
11/12/2008 Steven's Pharmacy [ARCHIVED] Los Angeles District Office New Drug/Labeling/False & Misleading Claims N/A *
11/12/2008 John Mellott Farm [ARCHIVED] Philadelphia District Office Illegal Drug Residue N/A *
11/07/2008 Hai Soon Leong Sdn Bhd [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated N/A *
11/04/2008 Innovative Neurotronic, Inc. [ARCHIVED] Dallas District Office CGMP/QSR/Medical Devices/Adulterated N/A *
11/03/2008 Blue Ribbon Fish Co. [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
11/03/2008 Spacelabs Healthcare Incorporated [ARCHIVED] Seattle District Office CGMP/QSR/Medical Devices/Adulterated N/A *
10/31/2008 Three Sister's Snacks Corporation [ARCHIVED] Minneapolis District Office Nutrition Labeling of Food/Misbranded N/A *
10/31/2008 Caraco Pharmaceutical Laboratories, Ltd [ARCHIVED] Detroit District Office CGMP Deviations N/A *
10/31/2008 Deltex Pharmaceuticals Inc [ARCHIVED] Dallas District Office CGMP For Drugs/Manufacture, Processing, Packing, Holding/Adulterated/Misbranded N/A *
10/31/2008 PrimaPharm Inc. [ARCHIVED] Los Angeles District Office Unapproved New Drug/Adulterated/Misbranded N/A *

 

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