Inspections, Compliance, Enforcement, and Criminal Investigations
2002 Warning Letters
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Warning Letters for 2002
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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 May 04, 2009
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| December 18, 2002 | Greater Miami Caterers Inc. | Florida District Office | Seafood HACCP/Adulterated | N/A * |
| December 18, 2002 | Gateway Blood Association | Kansas City District Office | Blood Products/Lacks Approved License for Interstate Commerce | N/A * |
| December 17, 2002 | Eastern Medical Equipment Distributors, Inc. | Florida District Office | CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing, Packing, or Holding/Adulterated | N/A * |
| December 17, 2002 | Paul Ramer Construction | Detroit District Office | New Drug/Adulterated | N/A * |
| December 17, 2002 | Minneapolis Radiology Associates, Ltd. | Minneapolis District Office | Mammography Quality Standards | N/A * |
| December 16, 2002 | Gulf Medical Services | Florida District Office | CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing, Packing, or Holding/Adulterated | N/A * |
| December 13, 2002 | VBM Medizintechnik GMBH | Center for Devices and Radiological Health | Quality System Regulation/Adulterated | N/A * |
| December 12, 2002 | Southern Herb Acquisition Co., LLC | Minneapolis District Office | New Drug/Misbranded | N/A * |
| December 12, 2002 | Primary Care Plus | Atlanta District Office | Mammography Quality Standards | N/A * |
| December 12, 2002 | Land O'Lakes | Kansas City District Office | Extralabel Drug Use in Animals/Adulterated | N/A * |
| December 11, 2002 | VISX Inc | Center for Devices and Radiological Health | Premarket Approval/Misbranded/Adulterated | N/A * |
| December 11, 2002 | Y & L Washington, Inc. | Seattle District Office | Seafood HACCP/Food Labeling/Adulterated/Misbranded | N/A * |
| December 11, 2002 | Virginia Seafood, LLC | Baltimore District Office | Food Labeling/Misbranded | N/A * |
| December 11, 2002 | Metropolitan Hospital Center | New York District Office | Mammography Quality Standards | N/A * |
| December 11, 2002 | Beaumont Products, Inc. | Atlanta District Office | Unapproved New Drug/GMP for Finished Pharmaceuticals/Misbranded | N/A * |
| December 10, 2002 | Serv-A-Pure Company | Detroit District Office | Quality System Regulation/Water Purification Systems/Adulterated | N/A * |
| December 10, 2002 | Superior Uniform Group, Inc. | Dallas District Office | QSR/Lack Premarket Approval/Registration Listing/Adulterated/Misbranded | N/A * |
| December 09, 2002 | Catholic Health Partners | Center for Biologics Evaluation and Research | IRB (Institutional Review Board) | N/A * |
| December 09, 2002 | E.M. Adams Co., Inc. | Florida District Office | Quality System Reguation/Adulterated | N/A * |
| December 06, 2002 | Walk, William M. | Chicago District Office | Edible Tissue/Adulterated | N/A * |
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