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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2000 Warning Letters

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Tobacco Retailer 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

 
Letter Issue Date Company Name Issuing Office Subject Close Out Date
August 29, 2000 Ameripec Inc. [ARCHIVED] Los Angeles District Office Current Good Manufacturing Practice in Manufacturing Packing or Holding Human Food N/A *
August 28, 2000 Zenith Goldline Laboratories [ARCHIVED] Florida District Office Verapamine Hydrochloride/Lacks "May Proceed Notice" or "Release Notice" N/A *
August 28, 2000 Liu's Bean Sprouts [ARCHIVED] Cincinnati District Office CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts N/A *
August 28, 2000 Taiwan Fuji Latex Company Ltd. [ARCHIVED] Center for Devices and Radiological Health Quality System Regulation/Condoms N/A *
August 28, 2000 Southwest Utah Home Health Agency [ARCHIVED] Denver District Office Medical Oxygen/GMP for Manufacture Processing Packing Holding Drugs/Adulterated N/A *
August 28, 2000 M. Zukerman and Co. Inc. [ARCHIVED] New Jersey District Office Seafood Processing Regulations/HACCP N/A *
August 25, 2000 Eye and Tissue Bank and Research Foundation Inc. [ARCHIVED] Baltimore District Office Tissue Bank N/A *
August 25, 2000 Qualigen Inc. [ARCHIVED] Center for Devices and Radiological Health Fast Pack Total PSA Assay/Misbranded/Lacks Premarket Approval N/A *
August 25, 2000 Down to Earth Sprout Farm [ARCHIVED] Seattle District Office CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts N/A *
August 25, 2000 Z'Strong International [ARCHIVED] Center for Devices and Radiological Health Bioelectrical Discharger/Misbranded/Lacks Premarket Approval N/A *
August 24, 2000 NCH Corporation [ARCHIVED] Dallas District Office Dermacoat Hand Cream/Lacks New Drug Application N/A *
August 24, 2000 Ameritek Inc. [ARCHIVED] 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 [ARCHIVED] Detroit District Office CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts N/A *
August 23, 2000 frscoMar Seafood Inc. [ARCHIVED] Florida District Office Seafood Processing Regulations/HACCP N/A *
August 22, 2000 Chestnut Ridge Family Health Center [ARCHIVED] New York District Office Mammography Standards N/A *
August 22, 2000 Aspen Valley Hospital [ARCHIVED] Denver District Office Shipment of Blood in Interstate Commerce by Unlicensed Facility N/A *
August 22, 2000 Halo Supply Company [ARCHIVED] Los Angeles District Office EverCLR/Lacks Approved New Drug Application N/A *
August 22, 2000 Alfa Medical Equipment Inc. [ARCHIVED] New York District Office Quality System/Good Manufacturing Practice/Dry-heat Sterilizers N/A *
August 22, 2000 Cortland Health Center [ARCHIVED] New York District Office Mammography Standards N/A *
August 21, 2000 Fish Hawk Fisheries Inc. [ARCHIVED] Seattle District Office Seafood Processing Regulations/HACCP N/A *



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ICECI Warning Letters

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