Inspections, Compliance, Enforcement, and Criminal Investigations
2002 Warning Letters
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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 * |
October 28, 2002 | Long Island Diagnostic Imaging | New York District Office | Mammography Quality Standards | N/A * |
October 25, 2002 | Cody, Kendall S. | New York District Office | Edible Tissue/Adulterated | N/A * |
October 25, 2002 | Becton Dickinson & Company | San Juan District Office | Quality System Regulation for Medical Devices/Labeling | N/A * |
October 24, 2002 | St. Joseph Medical Center | Seattle District Office | Mammography Quality Standards | N/A * |
October 23, 2002 | California Co-Packers LLC | San Francisco District Office | Seafood HACCP | N/A * |
October 23, 2002 | Bristol-Myers Squibb Manufacturing Company | San Juan District Office | CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing, Packing, or Holding/Adulterated | N/A * |
October 23, 2002 | Tellez, Juan L., M.D. | Center for Biologics Evaluation and Research | Clinical Investigator | N/A * |
October 23, 2002 | Biomedical Implant Technology, Inc. | Center for Devices and Radiological Health | Quality System Reguation/Adulterated | N/A * |
October 22, 2002 | Santa Paula Memorial Hospital | Los Angeles District Office | Mammography Quality Standards | N/A * |
October 22, 2002 | Life Enchancement Products, Inc. | Center for Drug Evaluation and Research | Dietary Supplements/Labeling/Misbranded | N/A * |
October 22, 2002 | Beaver Dam Community Hospital | Minneapolis District Office | Mammography Quality Standards | N/A * |
October 22, 2002 | Good Samaritan Health Systems | Kansas City District Office | GMP for Blood & Blood Components/Records & Reports | N/A * |
October 22, 2002 | Swedish Fish Company | Baltimore District Office | Good Manufacturing Practices Regulations for Food/Seafood HACCP | N/A * |
October 21, 2002 | Pioneer Medical Group, Inc - Long Beach | Los Angeles District Office | Mammography Quality Standards | N/A * |
October 21, 2002 | Zincomatic, Inc. | Denver District Office | New Drug/Adulterated/Misbranded | N/A * |
October 21, 2002 | Wilbur-Ellis Company | Denver District Office | Food Additive Permitted in Feed, Drinking Water of Animals/Unsafe Food Additive/Adulterated | N/A * |
October 21, 2002 | Talbert Medical Group - Huntington Beach | Los Angeles District Office | Mammography Quality Standards | N/A * |
October 18, 2002 | Inland Seafood | Atlanta District Office | Seafood HACCP | N/A * |
October 18, 2002 | Health Care Manufacturing, Inc. | Kansas City District Office | Quality System Reguation/Adulterated | N/A * |
October 18, 2002 | Harford Memorial Hospital | Baltimore District Office | Mammography Quality Standards | N/A * |
October 18, 2002 | Unico Holdings, Inc. | Florida District Office | CGMP in Manufacturing, Processing, Packing or Holding/CGMP for Finished Pharmaceuticals/Adulterated | N/A * |
October 18, 2002 | Hendersonville Gynecology & Obstetrics | New Orleans District Office | Mammography Quality Standards | N/A * |
October 17, 2002 | Drogueria Central | San Juan District Office | Drug Labeling/Misbranded | N/A * |
October 17, 2002 | Hanmi, Inc. | Chicago District Office | Seafood HACCP/CGMP Manufacturing, Packing or Holding Human Food/Adulterated | N/A * |
October 17, 2002 | Giliana & Huziran | Chicago District Office | Food Labeling/Misbranded | N/A * |
October 17, 2002 | International Gourmet Food | Baltimore District Office | Seafood HACCP | N/A * |
October 16, 2002 | Steinhatchee Fish Inc. | Florida District Office | Seafood HACCP/Adulterated | N/A * |
October 16, 2002 | D & D Catering Inc. | Florida District Office | Seafood HACCP/Adulterated | N/A * |
October 15, 2002 | Abbott Laboratories, Inc. | Dallas District Office | CGMP in Manufacturing, Processing, Packing or Holding/CGMP for Finished Pharmaceuticals/Adulterated | N/A * |
October 15, 2002 | Jackson-Madison County General Hospital | New Orleans District Office | Mammography Quality Standards | N/A * |
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