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 |
|---|---|---|---|---|
| November 04, 2002 | Breathe Easy Medical Equipment | Cincinnati District Office | CGMP in Manufacturing, Processing, Packing or Holding/CGMP for Finished Pharmaceuticals/Adulterated | N/A * |
| November 04, 2002 | Walgreen Company | Chicago District Office | New Drug (OTC) | N/A * |
| November 01, 2002 | Lactroport USA | Minneapolis District Office | Cheeses and Related Cheese Products /Misbranded | N/A * |
| November 01, 2002 | Miriam Santisteban Wysocki, M.D., Inc. | Los Angeles District Office | Mammography Quality Standards | N/A * |
| November 01, 2002 | Presbyterian Healthcare Services | Denver District Office | Blood & Blood Products/Adulterated | N/A * |
| November 01, 2002 | Diagnostic Imaging, Inc. | New York District Office | Performance Standard for Diagnostic X-ray Equipment | N/A * |
| November 01, 2002 | Tysons Food, Inc | New Orleans District Office | Current Good Manufacturing Practice for Medicated Feeds/Adulterated | N/A * |
| November 01, 2002 | Park Nicollet Health Systems | Minneapolis District Office | Mammography Quality Standards | N/A * |
| November 01, 2002 | UPC Medical Supplies, Inc. | Center for Devices and Radiological Health | Lack Premarket Approval for Promotional Claims | N/A * |
| October 31, 2002 | True World Foods, Inc. | Dallas District Office | Seafood HACCP | N/A * |
| October 31, 2002 | Requeson Cruz-Pitre | San Juan District Office | Current Good Manufacuring Practice Reuirement for Food Manufacuring/Adulterated | N/A * |
| October 31, 2002 | CIDEC Corporation | New York District Office | Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated | N/A * |
| October 31, 2002 | General Electric Company-Medical System | Dallas District Office | Performance Standards for Diagnostic X-ray Equipment | N/A * |
| October 30, 2002 | Heimann Systems Corporation | Center for Devices and Radiological Health | Safety Performance Standard for Cabinet X-ray Systems | N/A * |
| October 30, 2002 | AP Diagnostic Imaging, Inc. | New Jersey District Office | Mammography Quality Standards | N/A * |
| October 30, 2002 | Aqel, Raed, M.D. | Center for Devices and Radiological Health | Clinical Investigator | N/A * |
| October 29, 2002 | St. Aloisius Medical Center | Minneapolis District Office | Mammography Quality Standards | N/A * |
| October 29, 2002 | Superior Seafoods, Inc. | Detroit District Office | Seafood HACCP/Adulterated | N/A * |
| October 29, 2002 | Hurricane Seafood, Inc. | Florida District Office | Seafood HACCP/Adulterated | N/A * |
| October 29, 2002 | Best Formulations | Los Angeles District Office | CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing, Packing, or Holding/Adulterated | N/A * |
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