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 |
---|---|---|---|---|
December 29, 2000 | true World Foods Inc. | Denver District Office | Seafood HACCP | N/A * |
December 29, 2000 | House of Smoke Inc. | Denver District Office | Seafood HACCP/Adulterated | N/A * |
December 28, 2000 | Haribo of America Inc. | Baltimore District Office | Jellied Candy/Lacks | N/A * |
December 28, 2000 | Fox Chase Cancer Center | Philadelphia District Office | Mammography Standards | N/A * |
December 28, 2000 | Fox Chase Cancer Center | Philadelphia District Office | Mammography Standards | N/A * |
December 27, 2000 | Knox Hirons | Chicago District Office | Food/Cattle/Adulterated | N/A * |
December 27, 2000 | Peche de Puerto Rico Inc. | San Juan District Office | Seafood Processing Regulations/HACCP | N/A * |
December 27, 2000 | Walquist Farm | Chicago District Office | Food/Cattle/Adulterated | N/A * |
December 26, 2000 | American Bio Medica Corporation | Center for Devices and Radiological Health | Rapid Drug Screen/Adulterated/Lacks Premarket Approval/Misbranded | N/A * |
December 22, 2000 | Spectrum Health Betty Ford Breast Care Services | Detroit District Office | Mammography Standards | N/A * |
December 22, 2000 | Beverly Hills Diagnostic Breast Center | Los Angeles District Office | Mammography Standards | N/A * |
December 22, 2000 | Advanced Health Care | Minneapolis District Office | Mammography Standards | N/A * |
December 22, 2000 | East Palestine Family Medical Clinic Inc. | Cincinnati District Office | Mammography Standards | N/A * |
December 21, 2000 | P & L Schouten Dairy | Dallas District Office | Food/Cattle/Adulterated | N/A * |
December 21, 2000 | Westerly Hospital | New England District Office | Mammography Standards | N/A * |
December 21, 2000 | St. Mary's Center for Women's Health | Minneapolis District Office | Mammography Standards | N/A * |
December 21, 2000 | Washington Crab Company Inc. | Atlanta District Office | Seafood Processing Regulations/HACCP | N/A * |
December 20, 2000 | Banco de Sangre Humacao Inc. | San Juan District Office | Good Manufacting Practices for Blood and Components | N/A * |
December 20, 2000 | Alexander Community Hospital | Atlanta District Office | Mammography Standards | N/A * |
December 20, 2000 | Organon Teknika BV | Center for Drug Evaluation and Research | Postmarketing Adverse Drug Experience Reporting Requirements | N/A * |
December 20, 2000 | St. Mary's Gateway Health Center | Minneapolis District Office | Mammography Standards | N/A * |
December 20, 2000 | Elcat Company | New Orleans District Office | Methamphetamine Hydrochloride/Active Pharmaceutcal Ingredients/Adulterated | N/A * |
December 20, 2000 | Top Katch Seafood Inc. | Florida District Office | Seafood Processing Regulations/HACCP | N/A * |
December 19, 2000 | E.A. Conway Medical Center | New Orleans District Office | Mammography Standards | N/A * |
December 19, 2000 | Belford Seafood Co-Op | New Jersey District Office | Seafood Processing Regulations/HACCP | N/A * |
December 19, 2000 | U.S. Food Service Inc. | New England District Office | Seafood Processing Regulations/HACCP | N/A * |
December 19, 2000 | Kodiak Smoking and Processing | Seattle District Office | Seafood Processing Regulations/HACCP | N/A * |
December 18, 2000 | ADI Corporation | Center for Devices and Radiological Health | Television/Computer Monitor Factories/Automatic Detention | N/A * |
December 18, 2000 | Coram Healthcare | New Orleans District Office | Liquid Medical Oxygen/Adulterated | N/A * |
December 18, 2000 | Marukai Corporation | San Francisco District Office | Seafood Processing Regulations/HACCP | N/A * |
December 18, 2000 | Xinjiang Pharmaceutical Factory | Center for Drug Evaluation and Research | Active Pharmaceutical Ingredient Mfr Facility/Adulterated/Manufacturing Processing Packaging etc. | N/A * |
December 18, 2000 | Blue Light Inc. | New York District Office | New Drug/Misbranded/Adulterated | N/A * |
December 16, 2000 | Missa Bay Inc. | New Jersey District Office | Seafood Processing Regulations/HACCP | N/A * |
December 15, 2000 | C & J Seafood Inc. | New Orleans District Office | Seafood Processing Regulations/HACCP | N/A * |
December 15, 2000 | Upcountry Fishery Inc. | San Francisco District Office | Seafood Processing Regulations/HACCP | N/A * |
December 15, 2000 | Ultralite Enterprises Inc. | Atlanta District Office | Quality System Regulation/Phototherapy Units/Adulterated | N/A * |
December 15, 2000 | Murex Diagnostics Inc. | Center for Biologics Evaluation and Research | Quality System Regulation | N/A * |
December 15, 2000 | Ultralite Enterprises Inc. | Atlanta District Office | Quality System Regulation/Phototherapy Units/Misbranded/MDR Reporting/Adulterated | N/A * |
December 14, 2000 | Genentech Inc. | Center for Biologics Evaluation and Research | Good Manufacturing Practices for Finished Pharmaceuticals/Biological Products General Provisions | N/A * |
December 14, 2000 | San Dimas Community Hospital | Los Angeles District Office | Mammography Standards | N/A * |
December 14, 2000 | Tianjin Xin Xin Pharmaceutical Corporation | Center for Drug Evaluation and Research | Active Pharmaceutical Ingredient/Adulterated/FMP's Manufacturing Processing Packing etc. | N/A * |
December 14, 2000 | Airgas Norpac | Seattle District Office | Medical Gas/Adulterated | N/A * |
December 14, 2000 | Intercoastal Medical Group | Florida District Office | Mammography Standards | N/A * |
December 13, 2000 | Everett Clinic | Seattle District Office | Mammography Standards | N/A * |
December 12, 2000 | University OB-GYN Specialties Inc. | Cincinnati District Office | Mammography Standards | N/A * |
December 12, 2000 | Scholzen Products Company Inc. | Denver District Office | GMP for Finished Pharmaceuticals/Gas & Liquid Medical Oxygen/Adulterated | N/A * |
December 11, 2000 | Radiology Clinics of Laredo | Dallas District Office | Mammography Standards | N/A * |
December 11, 2000 | Leiner Health Products Inc. | Atlanta District Office | Good Manufacturing Practice for Finished Pharmaceuticals/Adulterated | N/A * |
December 11, 2000 | Holy Cross Hospital | Dallas District Office | Mammography Standards | N/A * |
December 11, 2000 | Chemrich Holdings Inc. | Los Angeles District Office | Manufacturing Facility/Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated | N/A * |
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