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
August 02, 2000	Berger Mitchel S. M.D.	Center for Biologics Evaluation and Research	Clinical Investigator	N/A *
August 02, 2000	Medical Technology Solutions Inc.	Cincinnati District Office	Performance Standards for Diagnostic X-ray Equipment	N/A *
August 02, 2000	Saliva Diagnostic Systems Inc.	Seattle District Office	Test Kits/Lacks Premarket Approval Export Notification Etc.	N/A *
August 01, 2000	Lincoln Hospital Medical Center	Los Angeles District Office	Mammography Standards	N/A *
August 01, 2000	Sea Source Inc.	Florida District Office	Mahi Mahi/Import Not Held for Inspection	N/A *
August 01, 2000	Sun Sprouts of Traverse City	Detroit District Office	CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts	N/A *
August 01, 2000	Norton Sound Health Corporation	Seattle District Office	Mammography Standards	N/A *
August 01, 2000	FX Wolrdwide Corporation	Florida District Office	Tylenot Caplets & Perfumery Products/Shipment Not Held Intact	N/A *
July 31, 2000	Edrich Farms Inc.	Baltimore District Office	CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts	N/A *
July 31, 2000	Amherst Radiology	New York District Office	Mammography Standards	N/A *
July 31, 2000	Hoffmann-LaRoche Inc.	San Juan District Office	Klonopin Tablets/Records & Reports/Stability Testing/Etc.	N/A *
July 28, 2000	Evergreen Fruit & Produce Company	Seattle District Office	CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts	N/A *
July 28, 2000	Sprout About	Seattle District Office	CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts	N/A *
July 28, 2000	Buena Suerte Veterinary Services LLC	Denver District Office	Extralabel Drug Use in animals/Drug Residue in edible Tissue/Adulterated	N/A *
July 28, 2000	Winona Memorial Hospital	Detroit District Office	Mammography Standards	N/A *
July 28, 2000	Lead Mammography Radiologist	Cincinnati District Office	Mammography Standards	N/A *
July 28, 2000	Sprout City Inc.	Seattle District Office	CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts	N/A *
July 28, 2000	Growing Business	Seattle District Office	CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts	N/A *
July 28, 2000	LadyBug Sprout Farm	Seattle District Office	CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts	N/A *
July 28, 2000	Ackerman Foods	Seattle District Office	CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts	N/A *
July 27, 2000	Outerbanks Seafood Co. Inc.	Atlanta District Office	Seafood Processing Regulations/HACCP	N/A *
July 27, 2000	Glovesworld Industries Inc.	Center for Devices and Radiological Health	Quality System Regulation/Patient Examination Gloves	N/A *
July 26, 2000	Fantasia Fresh Juice Company	Chicago District Office	Orange Juice Manufacturing Facility	N/A *
July 26, 2000	Summa Health System-Akron City Hospital	Cincinnati District Office	Mammography Standards	N/A *
July 26, 2000	Women's Health Center	Cincinnati District Office	Mammography Standards	N/A *
July 25, 2000	New York Diagnostic Medical Services Inc.	Center for Devices and Radiological Health	Mammography Standards	N/A *
July 25, 2000	Kee's Company	Seattle District Office	CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts	N/A *
July 25, 2000	Cape Qaulity Bluefin Inc.	New England District Office	Seafood Processing Regulations/HACCP	N/A *
July 25, 2000	Sprouts Garden	Seattle District Office	CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts	N/A *
July 25, 2000	Bier Steven J. M.D. and DiBlasio Mario L. M.D.	Center for Devices and Radiological Health	Mammography Standards	N/A *
July 25, 2000	Richard Ienst Dairy	San Francisco District Office	Food/Cattle	N/A *
July 25, 2000	P Flats Sprout Farm	Seattle District Office	CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts	N/A *
July 25, 2000	Sprouters Northwest Inc.	Seattle District Office	CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts	N/A *
July 25, 2000	M.F. Gomes and Sons Dairy	San Francisco District Office	Food/Cattle	N/A *
July 24, 2000	Carl Zeiss Jena Gmbh	Center for Devices and Radiological Health	Quality System Regulation/Surgical Laser Powered Instruments	N/A *
July 24, 2000	Griffith Micro Science Ltd.	Center for Devices and Radiological Health	Quality System Regulation/contract Sterilizer for Medical Devices	N/A *
July 24, 2000	South Bay Clam Company	Florida District Office	Whole Tuna/Import Not Held for Inspection	N/A *
July 24, 2000	Western Edge Inc.	Florida District Office	Food Products	N/A *
July 24, 2000	Textus Ningbo Manufacturing Company Ltd.	Center for Devices and Radiological Health	Quality System Regulation/Sterile Gauze & Bandage Compresses	N/A *
July 24, 2000	China Farm Inc.	Detroit District Office	Current Good Manufacturing Practice Requirements for Foods	N/A *
July 24, 2000	Datascope Corporation	Center for Devices and Radiological Health	VasoSeal ES Vascular Hemostasis Device/Promotional Claims/Labeling etc.	N/A *
July 24, 2000	British Express	Florida District Office	Food Products/Import Not Held for Inspection	N/A *
July 24, 2000	Cancer Detection Center	Los Angeles District Office	Mammography Standards	N/A *
July 24, 2000	New Moon Noodle Co.	Detroit District Office	Current Good Manufacturing Practice Requirements for Foods	N/A *
July 21, 2000	Share Corporation	Minneapolis District Office	OTC Topical Antimicrobial/Lacks New Drug Application	N/A *
July 21, 2000	Mei Mee Srpouting Inc.	Detroit District Office	Current Good Manufacturing Practice in Manufacturing Packing or Holding Human Food/Sprouts	N/A *
July 21, 2000	ADI Corporation	Center for Devices and Radiological Health	Quality Control & Testing Program	N/A *
July 21, 2000	CPC - Brown Clinic	Minneapolis District Office	Mammography Standards	N/A *
July 20, 2000	Bayer Corporation Consumer Care Division	Philadelphia District Office	Cipor HC Otic/Current Good Manufacturing Practices/Laboratory Controls	N/A *
July 20, 2000	Biora AB	Center for Devices and Radiological Health	Quality System Regulation/EMDOGAIN (dental bone fillng material)	N/A *

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