Inspections, Compliance, Enforcement, and Criminal Investigations
2000 Warning Letters
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Warning Letters for 2000
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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 26, 2009
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
August 14, 2000 | Oriental Wholesale Foods Inc. | New York District Office | CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts | N/A * |
August 14, 2000 | Chinese Bean Sprout Company | Denver District Office | Insanitary Conditions/Adulterated | N/A * |
August 14, 2000 | Wasilkowski Anthony F. M.D. | New York District Office | Mammography Standards | N/A * |
August 14, 2000 | Chung Wah Co. | Detroit District Office | Mung Bean Sprout Processing Operations/Insanitary Conditions/Adulterated | N/A * |
August 14, 2000 | Seramed Inc. | Minneapolis District Office | CGMP/Blood & Blood Components | N/A * |
August 14, 2000 | Stough Enterprises | Minneapolis District Office | CGMP/Blood & Blood Components | N/A * |
August 14, 2000 | LaFond Fisheries | Minneapolis District Office | Seafood Processing Regulations/HACCP | N/A * |
August 11, 2000 | Neverland Farms | Seattle District Office | CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts | N/A * |
August 11, 2000 | Evergreen Acres | Seattle District Office | CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts | N/A * |
August 11, 2000 | Country Fresh Products Inc. | Dallas District Office | CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts | N/A * |
August 11, 2000 | St. Joseph's Hospital of Chewelah | Seattle District Office | Mammography Standards | N/A * |
August 11, 2000 | Inland Orient Trading | Seattle District Office | CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts | N/A * |
August 11, 2000 | Ike's Fish Company | Seattle District Office | Seafood Processing Regulations/HACCP | N/A * |
August 11, 2000 | Baxter Healthcare Corporation | Chicago District Office | Aseptic Parenteral Manufacturing/cGMP Violations | N/A * |
August 11, 2000 | Ethicon Inc. | New Jersey District Office | Quality System Regulation/Endopouch Pro | N/A * |
August 11, 2000 | Jimyko Inc. dba Jameco Company | San Francisco District Office | Seafood Processing Regulations/HACCP | N/A * |
August 10, 2000 | T.B. Smith Seafood Co. Inc. | Atlanta District Office | Seafood Processing Regulations/HACCP | N/A * |
August 10, 2000 | Golden Pacific International Inc. | San Francisco District Office | Seafood Processing Regulations/HACCP | N/A * |
August 10, 2000 | Teleflex Inc. | Atlanta District Office | Quality System Regulation | N/A * |
August 10, 2000 | Austrade Inc. | Atlanta District Office | Energy Drinks/Failure to Hold an Entry Intact | N/A * |
August 09, 2000 | Newport Community Hospital | Seattle District Office | Mammography Standards | N/A * |
August 09, 2000 | North Point Dairy | Denver District Office | Edible Tissues/Adulterated | N/A * |
August 09, 2000 | Rocky Mountain Motel | Denver District Office | Soybean Sprout/Insanitary Conditions/Adulterated | N/A * |
August 09, 2000 | Best Fish Company LLC d.b.a. Crab Fresh | Seattle District Office | Seafood Processing Regulations/HACCP | N/A * |
August 09, 2000 | China Noodle Factory | San Francisco District Office | CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts | N/A * |
August 09, 2000 | Sun Sen Salad Co. Inc. | San Francisco District Office | CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts | N/A * |
August 09, 2000 | Silver Sprouts Ltd. | San Francisco District Office | CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts | N/A * |
August 08, 2000 | E. Excel International Inc. | Denver District Office | New Drugs/Dietary Supplements/Food Labeling/Misbranded | N/A * |
August 07, 2000 | Gunnison Valley Hospital | Dallas District Office | Mammography Standards | N/A * |
August 07, 2000 | Overland Medical Center | Dallas District Office | Mammography Standards | N/A * |
August 07, 2000 | Breast Center of Texoma | Dallas District Office | Mammography Standards | N/A * |
August 07, 2000 | Delta County Memorial Hospital | Dallas District Office | Mammography Standards | N/A * |
August 07, 2000 | Edmond Medical Center | Dallas District Office | Mammography Standards | N/A * |
August 07, 2000 | Abbott Laboratories | Chicago District Office | Medical Device Corrections and Removals/Infusion Pumps | N/A * |
August 04, 2000 | Dandy Day Corporation | Atlanta District Office | New Drug/Labeling/Misbranded | N/A * |
August 04, 2000 | Shanghai Co. Inc. | Seattle District Office | CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts | N/A * |
August 04, 2000 | Wigle John R. | Philadelphia District Office | Food/Cattle | N/A * |
August 04, 2000 | Falloncrest Farms | San Francisco District Office | Food/Cattle | N/A * |
August 04, 2000 | Mill Creek Family Practice Clinic | Seattle District Office | Mammography Standards | N/A * |
August 04, 2000 | Mon Chong Loong Trading Corporation | Florida District Office | Mushroom Dark Soy Sauce/Lacks "May Proceed Notice" or "Release Notice" | N/A * |
August 04, 2000 | Phoenix Medical Products | Nashville District Office | Quality System Regulation/Devices | N/A * |
August 04, 2000 | Omega Medical Imaging Inc. | Florida District Office | Quality System Regulation/Cardiac & Vascular Imaging Systems | N/A * |
August 04, 2000 | Progressive Chemical Research Ltd. | Center for Devices and Radiological Health | Contact Lenses | N/A * |
August 03, 2000 | Empressas La Famosa, Inc | San Juan District Office | Food Labeling/Adulterated/Misbranded | N/A * |
August 03, 2000 | LushLife Gardens | New Jersey District Office | CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts | N/A * |
August 03, 2000 | Almo Erzeugnisse Erzeugnisse Erwin Busch GmbH | Center for Devices and Radiological Health | Quality System Regulation/Disposable Syringes | N/A * |
August 03, 2000 | Allied Healthcare Products Inc. | Kansas City District Office | Quality System Regulation/Emergency Ventilators & Circumcision Clamps | N/A * |
August 03, 2000 | Hyperbaric Technologies Inc. | Dallas District Office | HyperTec Oyster Hybrid & Chambers/Lacks Premarket Approval/Not Substantially Equivalent | N/A * |
August 03, 2000 | Biotherapies Inc. | Detroit District Office | Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated | N/A * |
August 03, 2000 | Transylvania Community Hospital | Atlanta District Office | Mammography Standards | N/A * |
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