Inspections, Compliance, Enforcement, and Criminal Investigations
2005 Warning Letters
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Warning Letters issued in 2005
* 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 February 02, 2009
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
December 29, 2005 | Edgar Martin Dairy | Minneapolis District Office | Illegal Drug Residue /Adulterated | N/A * |
December 27, 2005 | Wellness Resources, Inc. | Minneapolis District Office | Labeling/Promotional Claims False & Misleading/New Drug/Misbranded | N/A * |
December 23, 2005 | Siouxland Community Blood Bank | Kansas City District Office | Current Good Manufacturing Practices Regulations for Blood & Blood Components/Adulterated | N/A * |
December 23, 2005 | Fujian Sky Food Company | Los Angeles District Office | Seafood HACCP/Adulterated | N/A * |
December 22, 2005 | Fukumaru Seafood Company | Los Angeles District Office | Seafood HACCP | N/A * |
December 22, 2005 | Paradise Farm Corporation | New England District Office | Juice HACCP/Adulterated | N/A * |
December 22, 2005 | Guidant Corporation | Minneapolis District Office | CGMP for Medical Devices/QS/Adulterated | N/A * |
December 21, 2005 | Lawsons Farm | New England District Office | Illegal Drug Residue /Adulterated | N/A * |
December 21, 2005 | Gold Eagle Cooperative | Kansas City District Office | Animal Proteins Prohibited in Ruminant Feed/Misbranded | N/A * |
December 21, 2005 | Clarkdale Fruit Farms Inc. | New England District Office | Juice HACCP | N/A * |
December 21, 2005 | Dore, David D., M.D. | Center for Devices and Radiological Health | Clinical Investigator | N/A * |
December 19, 2005 | Tidman, Raymond E., M.D. | Center for Drug Evaluation and Research | Clinical Investigator | N/A * |
December 16, 2005 | Seecor, Inc. | Dallas District Office | CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated | N/A * |
December 16, 2005 | Midwest Seafood, Inc. | Cincinnati District Office | Seafood HACCP/Adulterated | N/A * |
December 15, 2005 | Baltimore City Health Department | Center for Biologics Evaluation and Research | Institutional Review Board (IRB) | N/A * |
December 14, 2005 | Shelhigh, Inc. | New Jersey District Office | CGMP Requirement for Medical Devices/Lacks Premarket Approval Application/Adulterated | N/A * |
December 14, 2005 | Topway Enterprises, Inc. | Dallas District Office | CGMP Regulations for Foods/Seafood (HACCP) | N/A * |
December 13, 2005 | Ise Newberry, Inc. | Atlanta District Office | Control of Communicable Diseases/Adulterated | N/A * |
December 12, 2005 | Morrell Farm | New York District Office | Illegal Drug Residue | N/A * |
December 09, 2005 | MCT Medical Products | Dallas District Office | Current Good Manufacturing Practice for Medical Devices/Adulterated | N/A * |
December 09, 2005 | Milk Flow Dairy | Denver District Office | Illegal Drug Residue /Adulterated | N/A * |
December 08, 2005 | Michael Mumbulo | New York District Office | Illegal Drug Residue | N/A * |
December 07, 2005 | LifeScan, Inc. | San Francisco District Office | CGMP requirements for the Quality System Regulation/Medical Device Reporting/Adulterated/Misbranded | N/A * |
December 07, 2005 | American Eagle/Executive Airlines, Inc. | San Juan District Office | CGMP for Foods/Adulterated | N/A * |
December 06, 2005 | WaJa Farms, Inc | New York District Office | Illegal Drug Residue | N/A * |
December 05, 2005 | Two Brothers Seafood, Inc. | San Juan District Office | CGMP for Foods/Seafood HACCP/Adulterated | N/A * |
December 05, 2005 | Pedro Barba & Sons Inc. | San Juan District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | N/A * |
December 05, 2005 | IIT Research Institute | Center for Drug Evaluation and Research | GLP for non-clincal laboratory studies | N/A * |
December 05, 2005 | Carrington Laboratories, Inc | Dallas District Office | Insanitary Conditions/Adulterated/Misbranded | N/A * |
December 02, 2005 | Fabulous Fish Co. | Kansas City District Office | CGMP for Foods/Seafood HACCP/Adulterated | N/A * |
December 02, 2005 | Restorative Products, Inc. | Florida District Office | Medical Device Reporting Regulations/Quality System Regulation/Adulterated/Misbranded | N/A * |
December 02, 2005 | Rite-Dent Manufacturing Corp. | Florida District Office | Medical Device Reporting Regulations/Quality System Regulation/Adulterated/Misbranded | N/A * |
December 01, 2005 | Life Enhancement Products, Inc. | Center for Food Safety and Applied Nutrition | Food Labeling/Food Additive Misbranded | N/A * |
December 01, 2005 | Yu I Hsiang U.S.A. corp | Los Angeles District Office | Seafood HACCP/Adulterated | N/A * |
December 01, 2005 | Samson Medical Technologies, Inc. | New Jersey District Office | Labeling/New Drug/Misbranded | N/A * |
November 30, 2005 | YSIS, Incorporated | Cincinnati District Office | Current Good Manuafacturing Practice for Medical Devices/Adulterated/Misbranded | N/A * |
November 30, 2005 | Healthworks 2000 | Dallas District Office | Labeling/Promotional Claims False & Misleading/New Drug/Misbranded | N/A * |
November 30, 2005 | Iceland Health, Inc | Kansas City District Office | Labeling/Promotional Claims False & Misleading/New Drug/Misbranded | N/A * |
November 30, 2005 | Vitacost.com | Florida District Office | Labeling/Promotional Claims False & Misleading/New Drug/Misbranded | N/A * |
November 29, 2005 | Chozyn, LLC | New Jersey District Office | Labeling/Promotional Claims False & Misleading/New Drug/Misbranded | N/A * |
November 29, 2005 | BODeSTORE.com | New Jersey District Office | Labeling/Promotional Claims False & Misleading/New Drug/Misbranded | N/A * |
November 28, 2005 | Spectrum Chemicals & Laboratory Products, Inc | New Jersey District Office | Active Pharmaceutical Ingredients/Misbranded | N/A * |
November 28, 2005 | Sacred Mountain Management Inc | Denver District Office | Labeling/Promotional Claims False & Misleading/New Drug/Misbranded | N/A * |
November 23, 2005 | PRB Pharmaceuticals | Los Angeles District Office | Labeling/Promotional Claims False & Misleading/New Drug/Misbranded | N/A * |
November 23, 2005 | PolyCil Health Inc | Los Angeles District Office | Labeling/Promotional Claims False & Misleading/New Drug/Misbranded | N/A * |
November 23, 2005 | The Electrode Store, Inc. | Seattle District Office | Current Good Manufacturing Practices Requirements for Medical Devices/Adulterated | N/A * |
November 22, 2005 | NativeRemedies.com | Center for Biologics Evaluation and Research | Promotional Claims False & Misleading/Misbranded | N/A * |
November 22, 2005 | Milbank Mills Inc | Kansas City District Office | CGMP for Medicated Feeds/Adulterated | N/A * |
November 22, 2005 | Corin USA | Center for Devices and Radiological Health | Lacks Premarket Approval Application Adulterated | N/A * |
November 22, 2005 | Kramer Laboratories Inc. | Florida District Office | Labeling/Promotional Claims False & Misleading/New Drug/Misbranded | N/A * |
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