Inspections, Compliance, Enforcement, and Criminal Investigations
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
Posted on July 07, 2009
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
December 30, 2008 | Dongkuk Techco Rubber Ind. Sdn Bhd | Center for Devices and Radiological Health | CGMP/QSR/Adulterated | N/A * |
December 30, 2008 | Kidron Auction Inc. | Cincinnati District Office | Illegal Drug Residue | N/A * |
December 24, 2008 | Aunt Kitty's Foods, Inc. | New Jersey District Office | Food Labeling Misbranded | N/A * |
December 24, 2008 | Stoney Acres Calves | Detroit District Office | Illegal Drug Residue | N/A * |
December 22, 2008 | I-Flow Corporation | Los Angeles District Office | CGMP/QSR/Medical Devices/Adulterated | N/A * |
December 22, 2008 | Troyer, Todd | Cincinnati District Office | Illegal Drug Residue | N/A * |
December 22, 2008 | Columbia Presbyterian Medical Center | New York District Office | Deviation/Adulterated | N/A * |
December 22, 2008 | Newman's Own Organics | Center for Food Safety and Applied Nutrition | N/A * | |
December 22, 2008 | Newman's Own Organics | Center for Food Safety and Applied Nutrition | Federal Food, Drug and Cosmetic Act/Misbranded | N/A * |
December 16, 2008 | Ocean Beauty Seafoods, Inc. | Seattle District Office | Seafood HACCP | N/A * |
December 16, 2008 | Civic Center Pharmacy | Los Angeles District Office | New Drug, Unapproved | N/A * |
December 15, 2008 | Craig General Hospital | Dallas District Office | Deviation from Good Manufacturing Practice | N/A * |
December 10, 2008 | Virbac Inc. | Kansas City District Office | CGMP For Manufacturing, Packing, Storage or Installation/Adulterated/Misbranded | N/A * |
December 10, 2008 | Savec Health Systems | Center for Devices and Radiological Health | Premarket Approval/Misbranded/Adulterated | N/A * |
December 10, 2008 | High Tide Seafoods, Inc. | Seattle District Office | Seafood HACCP/CGMP for Foods/Adulterated | N/A * |
December 10, 2008 | Coca-Cola Company (The) | Center for Food Safety and Applied Nutrition | Labeling/False & Misleading Claims/Adulterated/Misbranded | N/A * |
December 08, 2008 | RGI Medical Manufacturing, Inc. | Florida District Office | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated | N/A * |
December 05, 2008 | Pneumex, Incorporated | Seattle District Office | Premarket Approval/Misbranded/Adulterated | N/A * |
December 05, 2008 | Douglas Bennett Farm | New England District Office | Illegal Drug Residue | N/A * |
December 04, 2008 | Haemonetics Corporation | Chicago District Office | CGMP/QSR/Medical Devices/Adulterated | N/A * |
December 04, 2008 | Carib Supply of St. Croix, Inc. | San Juan District Office | CGMP Manufacture, Processing, Packing or Holding of Human Drugs/Adulterated | N/A * |
December 03, 2008 | Kids Company Ltd Yugengaisha Kids | Center for Devices and Radiological Health | Device/Lacks Approved Premarket Application/Adulterated/Misbranded | N/A * |
December 01, 2008 | Vital Signs, Inc. | Center for Devices and Radiological Health | Premarket Approval/Misbranded/Adulterated | N/A * |
December 01, 2008 | Perich, Larry M | Baltimore District Office | Clinical Investigator | N/A * |
November 26, 2008 | B & C Calves/Livestock | Philadelphia District Office | Illegal Drug Residue | N/A * |
November 25, 2008 | Lett Us One Corporation | San Juan District Office | CGMP Manufacturing, Packing, or Holding Human Food/Adulterated | N/A * |
November 24, 2008 | Gonzalez Dairy, LLC | Denver District Office | Illegal Drug Residue | N/A * |
November 24, 2008 | PDS Manufacturing, Inc. | Dallas District Office | CGMP/QSR/Medical Devices/Adulterated | N/A * |
November 20, 2008 | Contract Medical Manufacturing | New England District Office | CGMP/QSR/Medical Devices/Adulterated | N/A * |
November 19, 2008 | Bernhard's Bakery, Inc. | Cincinnati District Office | CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated | N/A * |
November 19, 2008 | Goosefoot Acres, Inc. | Cincinnati District Office | Labeling/False & Misleading Claims/New Drug/Misbranded | N/A * |
November 18, 2008 | RHG & Company, Inc., dba Vital Nutrients | New England District Office | New Drug/Labeling/False & Misleading Claims/Misbranded | N/A * |
November 18, 2008 | Jeffrey Steinberg MD Inc., d/b/a The Fertility Institutes | Los Angeles District Office | Human Cells, Tissues & Cellular Products | N/A * |
November 18, 2008 | Surgical Implant Generation Network | Seattle District Office | CGMP for Medical Devices/QS/Adulterated | N/A * |
November 17, 2008 | Dabruzzi's Italian Foods, Inc. | Minneapolis District Office | Food Labeling/False & Misleading/Misbranded | N/A * |
November 14, 2008 | Eagle Parts and Products | Atlanta District Office | CGMP/QSR/Medical Devices/Adulterated | N/A * |
November 13, 2008 | Saudek, Christopher D., M.D. | Center for Devices and Radiological Health | Clinical Investigator | N/A * |
November 13, 2008 | American Association of Acupuncture and Bio-Energetic Medicine | Center for Devices and Radiological Health | Institutional Review Board (IRB) | N/A * |
November 13, 2008 | G.N.Y. Filet Fish Co., Inc. | New York District Office | Seafood HACCP/GMP for Foods/Adulterated | N/A * |
November 13, 2008 | Lam, Fred M.D. | Center for Devices and Radiological Health | Institutional Review Board (IRB) | N/A * |
November 13, 2008 | Saudek, Christopher D. MD | Center for Devices and Radiological Health | Clinical Investigator | N/A * |
November 13, 2008 | Artisan Specialty Foods | Chicago District Office | Seafood HACCP | N/A * |
November 13, 2008 | Rezai, Ali R, M.D | Center for Devices and Radiological Health | Clinical Investigator | N/A * |
November 12, 2008 | John M. Mellott Farm | Philadelphia District Office | Illegal Drug Residue | N/A * |
November 12, 2008 | John Mellott Farm | Philadelphia District Office | Illegal Drug Residue | N/A * |
November 12, 2008 | Steven's Pharmacy | Los Angeles District Office | New Drug/Labeling/False & Misleading Claims | N/A * |
November 07, 2008 | Hai Soon Leong Sdn Bhd | Center for Food Safety and Applied Nutrition | Seafood HACCP/CGMP for Foods/Adulterated | N/A * |
November 04, 2008 | Innovative Neurotronic, Inc. | Dallas District Office | CGMP/QSR/Medical Devices/Adulterated | N/A * |
November 03, 2008 | Blue Ribbon Fish Co. | New York District Office | Seafood HACCP/CGMP for Foods/Adulterated | N/A * |
November 03, 2008 | Spacelabs Healthcare Incorporated | Seattle District Office | CGMP/QSR/Medical Devices/Adulterated | N/A * |
Contact FDA
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Food and Drug Administration
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Rockville, MD 20857