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 *
August 21, 2000	Fish Hawk Fisheries Inc.	Seattle District Office	Seafood Processing Regulations/HACCP	N/A *
August 21, 2000	James Broderick Dairy Farm	Minneapolis District Office	Food/Raw Milk	N/A *
August 21, 2000	JDV International	Florida District Office	Shipment/Lacks "May Proceed Notice" or "Release Notice"	N/A *
August 21, 2000	Specialty Laboratories Inc.	Florida District Office	Reagents/Lacks "May Proceed Notice" or "Release Notice"	N/A *
August 18, 2000	Smoki Foods Inc.	Seattle District Office	Seafood Processing Regulations/HACCP	N/A *
August 18, 2000	Acon Laboratories Inc.	Center for Devices and Radiological Health	Devices/Lacks Premarket Approval	N/A *
August 18, 2000	Jack Davis & Associates Inc.	Atlanta District Office	Noni Tahiti/Lacks Premarket Approval/Misbranded	N/A *
August 18, 2000	Joe Monani Fish Co. Inc.	New York District Office	Seafood Processing Regulations/HACCP	N/A *
August 18, 2000	Alfred Louie Inc.	San Francisco District Office	CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts	N/A *
August 18, 2000	Diagnostica Stago Inc.	Center for Devices and Radiological Health	Biological Products Standards	N/A *
August 18, 2000	Kwok-Cheng Enterprises Inc.	Florida District Office	CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts	N/A *
August 18, 2000	eScreen Inc.	Center for Devices and Radiological Health	eScreen Drugs of Abuse/Lacks Premarket Approval	N/A *
August 18, 2000	Baranof Fisheries Ltd	Philadelphia District Office	Seafood Processing Regulations/HACCP	N/A *
August 18, 2000	Good Shepherd Sprout Farm	Seattle District Office	CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts	N/A *
August 18, 2000	Calabash Imaging Center	Atlanta District Office	Mammography Standards	N/A *
August 18, 2000	Chunco Foods Inc.	Kansas City District Office	CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts	N/A *
August 18, 2000	Delaware River and Bay Authority	New Jersey District Office	Notification of Use-Prohibited Classification	N/A *
August 18, 2000	Marjon Specialty Foods	Florida District Office	CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts	N/A *
August 18, 2000	Moberly Regional Medical Center	Dallas District Office	Mammography Standards	N/A *
August 18, 2000	Ho Ho Beansprouts Inc.	Detroit District Office	CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts	N/A *
August 17, 2000	Imperial Seafood Inc.	Florida District Office	Seafood Processing Regulations/HACCP	N/A *
August 17, 2000	Regional West Medical Center	Dallas District Office	Mammography Standards	N/A *
August 17, 2000	Northland Soy Products Inc.	Seattle District Office	CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts	N/A *
August 17, 2000	Southern Regional Medical Center	Atlanta District Office	Medical Oxygen / CGMP	N/A *
August 16, 2000	Perrigo Co.	Detroit District Office	Good Manufacturing Practices/Finished Pharmaceuticals Manufacturers Processing Packing etc.	N/A *
August 16, 2000	Pennington Greens	Seattle District Office	CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts	N/A *
August 15, 2000	Montag Thomas W. M.D.	Center for Biologics Evaluation and Research	Clinical Investigator	N/A *
August 15, 2000	Sweetwater Farms	Seattle District Office	CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts	N/A *
August 15, 2000	Labrada Bodybuilding Nutrition Inc.	Center for Food Safety and Applied Nutrition	Lean Body Hi-Protein Meal Replacement Bar/Labeling	N/A *
August 14, 2000	St. Francis Medical Center Institutional Review Board	Center for Devices and Radiological Health	IRB (Institutional Review Board)	N/A *

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