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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