Inspections, Compliance, Enforcement, and Criminal Investigations
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2007 Warning Letters
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Warning Letters for 2007
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* 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 27, 2007 | Mullet, Ivan | New York District Office | Illegal Drug Residue | N/A * |
| December 27, 2007 | Absolutely Fresh Seafood Company | Kansas City District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | N/A * |
| December 21, 2007 | Northwest Medical Physics Equipment, Inc. | Seattle District Office | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated | N/A * |
| December 21, 2007 | Medical Device Resource Corporation | San Francisco District Office | Premarket Approval/Misbranded/Adulterated | N/A * |
| December 21, 2007 | Cemac Foods Corporation | Philadelphia District Office | CGMP/Misbranded | N/A * |
| December 21, 2007 | Ambassador Meat Distributors Inc | Kansas City District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | N/A * |
| December 20, 2007 | Universal Enterprises Inc dba Air Service Hawaii | San Francisco District Office | Interstate Conveyance Sanitation Regulations/Provisional | N/A * |
| December 19, 2007 | Abbott Vascular, Inc. | Center for Devices and Radiological Health | Medical Devices/Adulterated/Misbranded | N/A * |
| December 18, 2007 | Keystone Food Products Inc | Philadelphia District Office | CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions | N/A * |
| December 18, 2007 | P-Ryton Corporation | New York District Office | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated | N/A * |
| December 17, 2007 | Siemens Medical Solutions, Ultrasound Division | Center for Devices and Radiological Health | Premarket Approval/Misbranded/Adulterated | N/A * |
| December 13, 2007 | Moisan Dairy | Seattle District Office | Illegal Drug Residue | N/A * |
| December 13, 2007 | G. Dundas Company Inc | Seattle District Office | CGMP/QSR/Medical Devices/Adulterated/Misbranded | N/A * |
| December 07, 2007 | Polychrome Medical, Inc | Minneapolis District Office | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated | N/A * |
| December 07, 2007 | Spinal, USA | New Orleans District Office | CGMP For Manufacturing, Packing, Storage or Installation/Adulterated/Misbranded | N/A * |
| December 05, 2007 | Wheatley, Susan J., M.D. | Center for Devices and Radiological Health | Clinical Investigator | N/A * |
| December 04, 2007 | G.D. Mathews and Sons Corporation dba Mathews Salad House Food Products | New England District Office | Seafood HACCP/Adulterated | N/A * |
| December 04, 2007 | Wild Edibles, Inc. | New York District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | N/A * |
| December 04, 2007 | Wild Edibles, Inc. | New York District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | N/A * |
| December 03, 2007 | Pacific Consolidated Industries LLC | Los Angeles District Office | CGMP For Manufacturing, Packing, Storage or Installation/Adulterated | N/A * |
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