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 |
---|---|---|---|---|
February 02, 2000 | Vysis Inc. | Center for Devices and Radiological Health | Aneu Vysion Assay/Lacks Premarket Approval/Misbranded | N/A * |
February 01, 2000 | South Beach Beverage Company | Center for Food Safety and Applied Nutrition | Food Labeling/Beverage | N/A * |
February 01, 2000 | Rosalis Crab Company | Florida District Office | Seafood Processing Regulations/HACCP | N/A * |
February 01, 2000 | Gifford Memorial Hospital | New England District Office | Mammography Standards | N/A * |
February 01, 2000 | ProSun Tanning Industries Inc | Florida District Office | Quality System Regulation/Tanning Beds | N/A * |
February 01, 2000 | Fred Schakel Dairy #2 | Los Angeles District Office | Food/Cattle | N/A * |
February 01, 2000 | Washington County Memorial Hospital | Detroit District Office | Mammography Standards | N/A * |
January 28, 2000 | Williamson Charles H. M.D. | Center for Devices and Radiological Health | Clinical Investigator | N/A * |
January 28, 2000 | Edelweiss farms Inc. | New York District Office | Food/Dairy Cow | N/A * |
January 27, 2000 | Robert's American Gourmet | Center for Food Safety and Applied Nutrition | Food Labeling/Spirulina Spirals & Low Fat Fruity Booty | N/A * |
January 27, 2000 | Kamco Seafood Inc. | Seattle District Office | Seafood Processing Regulations/HACCP | N/A * |
January 27, 2000 | Kenai Custom Seafoods | Seattle District Office | Seafood Processing Regulations/HACCP | N/A * |
January 26, 2000 | Hudson Transit Lines Inc. | New York District Office | Insanitary Conditions/Backflow Prevention Device | N/A * |
January 26, 2000 | Hugh Chatham Memorial Hospital | Atlanta District Office | Mammography Standards | N/A * |
January 26, 2000 | Wilvarger General Hospital | Dallas District Office | Mammography Standards | N/A * |
January 25, 2000 | Weber Laboratories Inc. | Los Angeles District Office | CGMP/Finished Pharmaceuticals | N/A * |
January 25, 2000 | Puratos Corporation | New York District Office | Food Import/Not held for FDA examination | N/A * |
January 25, 2000 | Specialty Tint | Center for Devices and Radiological Health | Tinted Contact Lenses/Lack Premarketing Approval/Misbranded | N/A * |
January 25, 2000 | Fridley Medical Center | Minneapolis District Office | Mammography Standards | N/A * |
January 24, 2000 | Canyon Crest Dairy | Denver District Office | Food/Dairy Cow | N/A * |
January 24, 2000 | Nature's Dairy | Denver District Office | Food/Dairy Cow | N/A * |
January 24, 2000 | Sundance Farms | Denver District Office | Food/Dairy Cow | N/A * |
January 24, 2000 | Countyline Dairy #2 | Denver District Office | Food/Dairy Cow | N/A * |
January 24, 2000 | X-ray Preceptor | Dallas District Office | Mammography Standards | N/A * |
January 24, 2000 | Arroyo Dairy | Denver District Office | Food/Dairy Cow | N/A * |
January 24, 2000 | Rockhill Dairy L.L.C. | Denver District Office | Food/Dairy Cow | N/A * |
January 24, 2000 | Chaslee Dairy | Denver District Office | Food/Dairy Cow | N/A * |
January 24, 2000 | Roswell Livestock Auction Co. | Denver District Office | Food/Dairy Cow | N/A * |
January 24, 2000 | Tom Visser Dairy | Denver District Office | Food/Dairy Cow | N/A * |
January 24, 2000 | NeuroControl Corp. | Cincinnati District Office | Quality System Regulation/NeuroControl Freehand System | N/A * |
January 24, 2000 | Pyramid Biological Corporation | Los Angeles District Office | Blood Products / Standard Operating Procedures | N/A * |
January 24, 2000 | Ahsley Valley Medical Center | Dallas District Office | Mammography Standards | N/A * |
January 24, 2000 | Faria Dairy | Denver District Office | Food/Dairy Cow | N/A * |
January 24, 2000 | Cottonwood Springs Dairy | Denver District Office | Food/Dairy Cow | N/A * |
January 24, 2000 | Vaz Dairy | Denver District Office | Food/Dairy Cow | N/A * |
January 21, 2000 | Kirklin Clinic | Nashville District Office | Mammography Standards | N/A * |
January 21, 2000 | St. Vincent Women's Center at Lazarus-Castleton | Detroit District Office | Mammography Standards | N/A * |
January 21, 2000 | Calvin Scott & Company Inc. | Denver District Office | Prescription Non-prescription Drug Repackaging Relabeling/CGMP | N/A * |
January 21, 2000 | Tule River Dairy | San Francisco District Office | Food/Cattle | N/A * |
January 20, 2000 | Entringer Bakeries Inc. | New Orleans District Office | Insanitary Conditions | N/A * |
January 20, 2000 | Phillips Medical Systems No.Amerca | New England District Office | X-ray CAT System/Misbranded | N/A * |
January 19, 2000 | UHHS Bedford Medical Center | Cincinnati District Office | Mammography Standards | N/A * |
January 19, 2000 | Jefferson Hospital | Atlanta District Office | Mammography Standards | N/A * |
January 19, 2000 | Kosma-Kare Canada Inc. | Center for Devices and Radiological Health | Quality System Regulation/Medical Adhesive Bandages/Adulterated | N/A * |
January 19, 2000 | Medi-Royale Pastex Inc | Center for Devices and Radiological Health | Quality System Regulation/Medical Adhesive Bandages | N/A * |
January 19, 2000 | CryoGen Inc. | Center for Devices and Radiological Health | First Option Uterine Cryoblation Therapy/Lacks Premarket Approval/Misbranded | N/A * |
January 14, 2000 | Chilean Fish Corporation | Florida District Office | Seafood Processing Regulations/HACCP | N/A * |
January 14, 2000 | Mc6 Cattle Feeders Inc. | Dallas District Office | Food/Cattle | N/A * |
January 14, 2000 | McFarling Foods Inc. | Detroit District Office | Seafood Processing Regulations/HACCP | N/A * |
January 14, 2000 | Gretna Drug Company Inc. | Baltimore District Office | Medical Gases / CGMP | N/A * |
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