2000 Warning Letters

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Tobacco Retailer Warning Letters

 

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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