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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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2000 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
September 06, 2000 New Pacific Inc. Center for Devices and Radiological Health Laser Product Performance Standards/Laser Light Show/Electronic Product Radiation Control N/A *
September 06, 2000 BCA Internaional Inc. Florida District Office Hema-Strip HIV-1/2 Test Kit/Lacks Investigational Device Exemption/Export Listing Violation N/A *
September 06, 2000 International Diagnostic & Medical Supply Corporation Florida District Office Hema-Strip HIV-1/2 Test Kit/Lacks Investigational Device Exemption/Export Listing Violation N/A *
September 06, 2000 Woman's Clinic New Orleans District Office Mammography Standards N/A *
September 06, 2000 Cape Atlantic Medical Inc. New Jersey District Office Medical Oxygen / CGMP N/A *
September 06, 2000 Jerome Stevens Pharmaceuticals Inc. New York District Office Digoxin Tablets/Good Manufacturing Practices for Finished Pharmaceuticals N/A *
September 05, 2000 San Gennaro Foods Inc. Seattle District Office Polenta/Production Processing Controls Acidified Foods etc. N/A *
September 05, 2000 Imaging Centers of Anaheim / Tan Tran M.D. Inc. Los Angeles District Office Mammography Standards N/A *
September 05, 2000 Shands Jacksonville Medical Center Florida District Office Mammography Standards N/A *
September 05, 2000 Jonlly Fruits, Inc. San Juan District Office Labeling/Adulterated/Misbranded N/A *
September 05, 2000 Bolivar General Hospital New Orleans District Office Mammography Standards N/A *
September 05, 2000 Davis Dairy Farm New England District Office Food/Dairy Cow N/A *
September 01, 2000 DeLonghi S.p.A Center for Devices and Radiological Health Federal Performance Standard for Microwave Ovens N/A *
September 01, 2000 Viking Village Inc. New Jersey District Office Seafood Processing Regulations/HACCP N/A *
September 01, 2000 Diagnostic Medical Group of Southern California Los Angeles District Office Mammography Standards N/A *
September 01, 2000 Slim Center Florida District Office Body Gel/Lacks "May Proceed Notice" or "Release Notice" N/A *
August 31, 2000 Calco Bean Sprouts Inc. Los Angeles District Office CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts N/A *
August 31, 2000 Pear Garden Produce Los Angeles District Office CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts N/A *
August 31, 2000 Nobel Biocare AB Center for Devices and Radiological Health Quality System Regulation/Sterile Dental Implants & Dental Surgical Instruments N/A *
August 31, 2000 Orange Bean Sprouts Los Angeles District Office CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts N/A *



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ICECI Warning Letters

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