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 29, 2000	In Flight Duty Free Shop Inc.	Florida District Office	Travel Kit Toothpaste Mouthwash etc./Lacks "May Proceed Notice" or "Release Notice"	N/A *
August 28, 2000	Southwest Utah Home Health Agency	Denver District Office	Medical Oxygen/GMP for Manufacture Processing Packing Holding Drugs/Adulterated	N/A *
August 28, 2000	Liu's Bean Sprouts	Cincinnati District Office	CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts	N/A *
August 28, 2000	Zenith Goldline Laboratories	Florida District Office	Verapamine Hydrochloride/Lacks "May Proceed Notice" or "Release Notice"	N/A *
August 28, 2000	Taiwan Fuji Latex Company Ltd.	Center for Devices and Radiological Health	Quality System Regulation/Condoms	N/A *
August 28, 2000	M. Zukerman and Co. Inc.	New Jersey District Office	Seafood Processing Regulations/HACCP	N/A *
August 25, 2000	Qualigen Inc.	Center for Devices and Radiological Health	Fast Pack Total PSA Assay/Misbranded/Lacks Premarket Approval	N/A *
August 25, 2000	Eye and Tissue Bank and Research Foundation Inc.	Baltimore District Office	Tissue Bank	N/A *
August 25, 2000	Down to Earth Sprout Farm	Seattle District Office	CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts	N/A *
August 25, 2000	Z'Strong International	Center for Devices and Radiological Health	Bioelectrical Discharger/Misbranded/Lacks Premarket Approval	N/A *
August 24, 2000	NCH Corporation	Dallas District Office	Dermacoat Hand Cream/Lacks New Drug Application	N/A *
August 24, 2000	Ameritek Inc.	Seattle District Office	Quality System Regulation/dBest One-Step HIV1/HIV2 Test Kit/Lacks Application for Premarket Approval	N/A *
August 23, 2000	Lake Sun Company	Detroit District Office	CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts	N/A *
August 23, 2000	frscoMar Seafood Inc.	Florida District Office	Seafood Processing Regulations/HACCP	N/A *
August 22, 2000	Halo Supply Company	Los Angeles District Office	EverCLR/Lacks Approved New Drug Application	N/A *
August 22, 2000	Alfa Medical Equipment Inc.	New York District Office	Quality System/Good Manufacturing Practice/Dry-heat Sterilizers	N/A *
August 22, 2000	Cortland Health Center	New York District Office	Mammography Standards	N/A *
August 22, 2000	Chestnut Ridge Family Health Center	New York District Office	Mammography Standards	N/A *
August 22, 2000	Aspen Valley Hospital	Denver District Office	Shipment of Blood in Interstate Commerce by Unlicensed Facility	N/A *
August 21, 2000	JMS Products Inc.	Florida District Office	Fresh Grouper/Lacks "May Proceed Notice" or "Release Notice"	N/A *

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