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 |
---|---|---|---|---|
July 06, 2000 | Caroca Pharmaceutical Laboratories Ltd. | Detroit District Office | Good Manufacturing Practices for Finished Pharmaceuticals | N/A * |
July 06, 2000 | Inovo Inc. | Florida District Office | Quality System Regulation/Medical Devices | N/A * |
July 06, 2000 | Open MRI of Englewood Cliffs | New Jersey District Office | Mammography Standards | N/A * |
July 06, 2000 | Pueblo Mammography Center | Dallas District Office | Mammography Standards | N/A * |
July 05, 2000 | Clinical Science Laboratories Inc. | New England District Office | Drug Testing Laboratory/GMP Regulations/Laboratory Controls/Records & Rpts/Personnel Qualifications | N/A * |
July 05, 2000 | Chesapeake General Hospital | Baltimore District Office | Mammography Standards | N/A * |
July 05, 2000 | Winchester Women's Specialists | Baltimore District Office | Mammography Standards | N/A * |
July 05, 2000 | Dioceses of Lafayette Catholic Schools | New Orleans District Office | Insanitary Conditions/Food Storage Warehouse | N/A * |
July 03, 2000 | Institute for Human Gene Therapy | Center for Biologics Evaluation and Research | GLP (Good Laboratory Practices) | N/A * |
June 30, 2000 | Beverly Hills Diagnostic Imaging | Los Angeles District Office | Mammography Standards | N/A * |
June 30, 2000 | A & L Laboratories | Minneapolis District Office | Good Manufacturing Practices for Finished Pharmaceuticals/Veterinary Drug Manufacturing Facility | N/A * |
June 30, 2000 | Shafer's Farm | New York District Office | Food/Cattle | N/A * |
June 30, 2000 | Daniel Freeman Outpatient Imaging | Los Angeles District Office | Mammography Standards | N/A * |
June 30, 2000 | Saint Vincent Medical Center | Los Angeles District Office | Mammography Standards | N/A * |
June 30, 2000 | Advanced Professional Imaging Medical Group | Los Angeles District Office | Mammography Standards | N/A * |
June 30, 2000 | Eastern Seafood Company Inc. | Chicago District Office | Seafood Processing Regulations/HACCP | N/A * |
June 30, 2000 | Phoenix Bean Products | Chicago District Office | CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts | N/A * |
June 30, 2000 | Somnus Medical Technologies Inc. | San Francisco District Office | Quality System Regulation/Somnoplasty Devices | N/A * |
June 29, 2000 | Mueller Sports Medicine Inc. | Minneapolis District Office | Tropical Antifungal Drug Products/Lacks New Drug Approval/Misbranded | N/A * |
June 29, 2000 | Dimequip | Center for Devices and Radiological Health | Quality System Regulation/Feeding Tubes Scalp Vein Sets Etc. | N/A * |
June 29, 2000 | Kewanee Hospital Association | Chicago District Office | Medical Gases / CGMP | N/A * |
June 28, 2000 | Delaware River and Bay Authority | New Jersey District Office | Insanitary Conditions/Motor Vessels | N/A * |
June 28, 2000 | Orca Bay Foods Inc. | Seattle District Office | Seafood Processing Regulations/HACCP | N/A * |
June 28, 2000 | New York's Bean Sprout Inc. | New York District Office | Unsanitary Conditions/GMP/Bean Sprout Production Facility | N/A * |
June 28, 2000 | Luen Hing Sprouts Inc. | New York District Office | Unsanitary Conditions/GMP/Bean Sprout Production Facility | N/A * |
June 28, 2000 | Ho Kong Bean Sprout Co. Inc. | New England District Office | Insanitary Conditions/Mung Bean Sprouts | N/A * |
June 27, 2000 | Merck Manufacturing Division | New Jersey District Office | Manufacturing Facility/GMP/Mnufacture of Active Pharmaceutical | N/A * |
June 27, 2000 | ITW Dymon | Kansas City District Office | Quality System Regulation/General Purpose Disinfectants | N/A * |
June 27, 2000 | United States Blood Band | Florida District Office | Blood Bank/CGMP/Finished Pharmaceuticals | N/A * |
June 27, 2000 | Delicious Foods Co. | San Francisco District Office | Insanitary Conditions | N/A * |
June 27, 2000 | Clinic for Women of Central Mississippi P.A. | New Orleans District Office | Mammography Standards | N/A * |
June 26, 2000 | Honey Smoked Fish Company LLC | Denver District Office | Seafood Processing Regulations/HACCP | N/A * |
June 26, 2000 | Calco of Seattle Inc. | Seattle District Office | Current Manufacturing Practice in Manufacturing Packing or Holding Human Food/Sprouts | N/A * |
June 26, 2000 | Curran Beansprout Co. Inc. | New England District Office | Insanitary Conditions/Mung Bean Sprouts | N/A * |
June 26, 2000 | Chester Labs Inc. | Cincinnati District Office | Quality System Regulation/Gels & Lotions | N/A * |
June 26, 2000 | Scientich Laboratories Inc. | New Jersey District Office | Testing Laboratory/Analyses Performances/Lack Test Method Validation & General Laboratory Practices | N/A * |
June 23, 2000 | Central Diagnostic Imaging | New York District Office | Mammography Standards | N/A * |
June 23, 2000 | U.S. Naval Hospital - Okinawa | Dallas District Office | Mammography Standards | N/A * |
June 23, 2000 | Straub Clinic - Milinani | San Francisco District Office | Marketing Clearance/Conserve PLUS | N/A * |
June 22, 2000 | Poly Implants Protheses Sa | Center for Devices and Radiological Health | Quality System Regulation/Saline Pre-filled Mammary Implants | N/A * |
June 22, 2000 | Woman's Health Pavilion | New York District Office | Mammography Standards | N/A * |
June 22, 2000 | DeJager Dariy South | San Francisco District Office | Food/Dairy Cow | N/A * |
June 22, 2000 | OmniSonics Medical Technologies Inc. | Center for Devices and Radiological Health | Ultrasonic Probes/Promotional Claims | N/A * |
June 22, 2000 | Solocare Pharmaceuticals Inc. | Minneapolis District Office | Folic Acid Products/Lacks Approved New Drug Application/Misbranded | N/A * |
June 22, 2000 | Tahiti Naturel USA Inc. | Los Angeles District Office | Noni Tahiti/Lacks Approved New Drug Application/Misbranded | N/A * |
June 21, 2000 | Zinke Dairy | Los Angeles District Office | Food/Cattle | N/A * |
June 21, 2000 | Garcia Brothers Dairy | San Francisco District Office | Food/Cattle | N/A * |
June 21, 2000 | Darrell Kong Bean Sprout and Noodle Manufacturing | San Francisco District Office | Insanitary Conditions | N/A * |
June 21, 2000 | Kopp Elliot J. M.D. | Center for Biologics Evaluation and Research | Clinical Investigator | N/A * |
June 21, 2000 | Abacherli Dairy | Los Angeles District Office | Food/Cattle | N/A * |
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