Inspections, Compliance, Enforcement, and Criminal Investigations
2004 Warning Letters
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Warning Letters issued in 2004
* 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 May 04, 2009
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
December 01, 2004 | Bearden Sandwich Co., Inc. | New Orleans District Office | Seafood HACCP/Adulterated | N/A * |
November 29, 2004 | Novartis Animal Health Services AG | Atlanta District Office | Adverse Drug Experience Reporting Requirements | N/A * |
November 29, 2004 | Celsis Laboratory Group, St. Louis Division | Center for Drug Evaluation and Research | GLP for Non-Clinical Laboratory Studies | N/A * |
November 24, 2004 | Berne Hi Way Hatchery, Inc. | Detroit District Office | CGMP for Medicated Feeds/Adulterated | N/A * |
November 24, 2004 | Sooil Development Co., Ltd | Center for Devices and Radiological Health | CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated | N/A * |
November 23, 2004 | Kegelmaster 2000 Ltd. | Florida District Office | CGMP for Medical Devices/QSR/Adulterated/Misbranded | N/A * |
November 23, 2004 | Thuemmel Dairy, Inc. | Detroit District Office | Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated | N/A * |
November 22, 2004 | Aurora Imaging Technology, Inc. | New England District Office | Quality System Regulation for Medical Devices/Adulterated | N/A * |
November 22, 2004 | LAR Manufacturing, LLC | Florida District Office | Quality System Regulation for Medical Devices/Adulterated | N/A * |
November 22, 2004 | Moshirfar, Majid, M.D. | Center for Devices and Radiological Health | Clinical Investigator | N/A * |
November 22, 2004 | Miracle Fish, Inc. | Florida District Office | Seafood HACCP | N/A * |
November 19, 2004 | Protherics, Inc. | Center for Biologics Evaluation and Research | Promotional Claims/False & Misleading | N/A * |
November 19, 2004 | Ortek AG | Center for Devices and Radiological Health | CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated | N/A * |
November 19, 2004 | Pharmachem Laboratories, Inc. | New Jersey District Office | Dietary Supplement/Labeling/False & Misleading Claims/Misbranded | N/A * |
November 19, 2004 | Jomara Seafood, Inc. | Florida District Office | Seafood HACCP/Adulterated | N/A * |
November 19, 2004 | DiGiorgio Corp. | New Jersey District Office | Seafood HACCP/Adulterated | N/A * |
November 19, 2004 | Ferndale Laboratories, Inc. | Detroit District Office | Lacks Approved New Drug Application/Labeling/Misbranded | N/A * |
November 19, 2004 | ATF Fitness Products, Inc. | Philadelphia District Office | Dietary Supplement/Labeling/Adulterated | N/A * |
November 19, 2004 | Osprey Seafood of California, Inc. | San Francisco District Office | Seafood HACCP/Adulterated | N/A * |
November 18, 2004 | LA Dorada Coral Gables, Inc. | Florida District Office | Seafood HACCP | N/A * |
November 18, 2004 | Parrish & Heimbecker Limited | Seattle District Office | Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded | N/A * |
November 17, 2004 | Community Hospital & Rehabilitation Center of Los Gatos | San Francisco District Office | Mammography Quality Standards | N/A * |
November 17, 2004 | Nuclear Cardio Systems, Inc. | Denver District Office | CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated | N/A * |
November 17, 2004 | Constantine, Niel T., Ph.D. | Center for Biologics Evaluation and Research | Clinical Investigator | N/A * |
November 17, 2004 | Pajunk GmbH | Center for Devices and Radiological Health | CGMP for Medical Devices/QSR/Adulterated/Misbranded | N/A * |
November 17, 2004 | Amsterdam, Daniel, Ph.D. | Center for Biologics Evaluation and Research | Clinical Investigator | N/A * |
November 16, 2004 | MED-EL ELEKTRO-MEDIZINISCHE GERATE GmbH | Center for Devices and Radiological Health | CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated | N/A * |
November 15, 2004 | Upscale Foods, Inc. | Minneapolis District Office | Food Labeling/Misbranded | N/A * |
November 12, 2004 | Clarity, Inc. | New Orleans District Office | CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated | N/A * |
November 10, 2004 | Alveolus, Inc. | Atlanta District Office | CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated | N/A * |
November 09, 2004 | South Florida Medical Corporation | Florida District Office | CGMP for Oxygen/Manufacturing, processing, packing, storage & holding/Adulterated | N/A * |
November 09, 2004 | Germiphene Corporation | Center for Devices and Radiological Health | CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated | N/A * |
November 09, 2004 | Northern Implants L.L.C. | Baltimore District Office | CGMP/QSR/Medical Devices/Adulterated | N/A * |
November 08, 2004 | AMF Support Surfaces, Inc. | Los Angeles District Office | Lacks Approved Premarket Application/Adulterated | N/A * |
November 08, 2004 | Spandet Dairy, Inc. | Dallas District Office | Extralabel Drug Use in Animals/Adulterated | N/A * |
November 05, 2004 | Synthes, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Device Reporting/Adulterated | N/A * |
November 05, 2004 | VitalCare Group, Inc. | Florida District Office | CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated | N/A * |
November 05, 2004 | Purington, Timothy W. | Center for Biologics Evaluation and Research | Clinical Investigator | N/A * |
November 04, 2004 | Kaiser Permanente Medical Center-Vallejo | San Francisco District Office | Mammography Quality Standards | N/A * |
November 03, 2004 | Great Atlantic Trading | Atlanta District Office | Seafood HACCP/Adulterated | N/A * |
November 02, 2004 | Reid's Bus Service | Kansas City District Office | Interstate Conveyance Sanitation Regulations | N/A * |
November 02, 2004 | Blood Net USA, Inc. | Florida District Office | CGMP for Blood & Blood Components/Adulterated | N/A * |
November 02, 2004 | Liko, Inc. | New England District Office | CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated | N/A * |
November 02, 2004 | Rhody Dairy | Seattle District Office | Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated | N/A * |
November 01, 2004 | Shin Chang Medical Co., Ltd. | Center for Devices and Radiological Health | CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated | N/A * |
November 01, 2004 | ABC Compounding Company, Inc. | Atlanta District Office | Lacks Approved New Drug Application/Adulterated/Misbranded | N/A * |
October 29, 2004 | VitalCare Group, Inc. | Center for Devices and Radiological Health | CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated | N/A * |
October 28, 2004 | Henry, Gary | Cincinnati District Office | CGMP for Medicated Feeds/Unapproved New Animal Drug/Adulterated | N/A * |
October 27, 2004 | Rick's Gulf Tex Seafood, Inc. | Dallas District Office | Seafood HACCP/Adulterated | N/A * |
October 26, 2004 | The One and Only Fashion Beauty Group, Inc. | Center for Devices and Radiological Health | Contact Lenses/Labeling/Adulterated/Misbranded | N/A * |
Contact FDA
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Food and Drug Administration
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