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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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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
May 11, 2000 Focus Imaging Group Inc. Florida District Office Diagnostic Ultrasound Equipment/Lacks Premarket Approval/Misbranded N/A *
May 10, 2000 South Bend Packers Inc. Seattle District Office Seafood Processing Regulations/HACCP N/A *
May 10, 2000 Dean Health System Inc. Minneapolis District Office Mammography Standards N/A *
May 10, 2000 Home Care Equipment Inc. Baltimore District Office Medical Gases / CGMP N/A *
May 10, 2000 Hocking Valley Community Hospital Cincinnati District Office Mammography Standards N/A *
May 10, 2000 Paragon Implant Company Center for Devices and Radiological Health Paragon Swiss Plus Implant System/Promotional Claims/Lacks Approved Pre-market Application N/A *
May 09, 2000 KV Pharmaceutical Company Kansas City District Office Drug Manufacturing Operations/CGMP deviations N/A *
May 09, 2000 Wheeler Seafoods Inc. Seattle District Office Seafood Processing Regulations/HACCP N/A *
May 09, 2000 Posey Crab Company Florida District Office Seafood Processing Regulations/HACCP N/A *
May 09, 2000 Louisiana Substance Abuse Clinic Inc. New Orleans District Office Narcotic Treatment Standards Violations N/A *
May 09, 2000 Petersburg Medical Center Seattle District Office Mammography Standards N/A *
May 09, 2000 Interim Penn Memorial Hospital Atlanta District Office Mammography Standards N/A *
May 08, 2000 MedGyn Products Inc. Chicago District Office Quality System Regulation/ Obstetrical & Gynecological Devices N/A *
May 08, 2000 Newport Hospital and Clinic Dallas District Office Mammography Standards N/A *
May 08, 2000 Vista Mundo Inc. Florida District Office St. Lucia Eye Drops/Lacks Approved New Drug Application/Promotional Claims/Labeling/Misbranded N/A *
May 08, 2000 Gulf Go-Fers Incorporated Florida District Office Seafood Processing Regulations/HACCP N/A *
May 08, 2000 Schering-Plough Laboratories San Juan District Office Human Veterinary Pharmaceutical Manufacturing Facility/CGMP/Finished Pharmaceuticals N/A *
May 08, 2000 Valley National Gases Inc. New Jersey District Office Finished Pharmaceuticals/Oxygen Repackaging Facility/CGMP N/A *
May 08, 2000 DBA Get Huge Los Angeles District Office Trican (tiratricol)/Unapproved New Drug Application/Misbranded/Not a Dietary Supplement N/A *
May 08, 2000 Biosil Limited Center for Devices and Radiological Health Medical Devices Regulation/Saline Fill Mammary Implants N/A *



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ICECI Warning Letters

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