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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2008 Warning Letters

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Warning Letters issued in 2008

 

* 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
December 04, 2008 Carib Supply of St. Croix, Inc. [ARCHIVED] San Juan District Office CGMP Manufacture, Processing, Packing or Holding of Human Drugs/Adulterated N/A *
December 03, 2008 Kids Company Ltd Yugengaisha Kids [ARCHIVED] Center for Devices and Radiological Health Device/Lacks Approved Premarket Application/Adulterated/Misbranded N/A *
December 01, 2008 Vital Signs, Inc. [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated N/A *
December 01, 2008 Perich, Larry M [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
November 26, 2008 B & C Calves/Livestock [ARCHIVED] Philadelphia District Office Illegal Drug Residue N/A *
November 25, 2008 Lett Us One Corporation [ARCHIVED] San Juan District Office CGMP Manufacturing, Packing, or Holding Human Food/Adulterated N/A *
November 24, 2008 Gonzalez Dairy, LLC [ARCHIVED] Denver District Office Illegal Drug Residue N/A *
November 24, 2008 PDS Manufacturing, Inc. [ARCHIVED] Dallas District Office CGMP/QSR/Medical Devices/Adulterated N/A *
November 20, 2008 Contract Medical Manufacturing [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated N/A *
November 19, 2008 Goosefoot Acres, Inc. [ARCHIVED] Cincinnati District Office Labeling/False & Misleading Claims/New Drug/Misbranded N/A *
November 19, 2008 Bernhard's Bakery, Inc. [ARCHIVED] Cincinnati District Office CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated N/A *
November 18, 2008 Jeffrey Steinberg MD Inc., d/b/a The Fertility Institutes [ARCHIVED] Los Angeles District Office Human Cells, Tissues & Cellular Products N/A *
November 18, 2008 Surgical Implant Generation Network [ARCHIVED] Seattle District Office CGMP for Medical Devices/QS/Adulterated N/A *
November 18, 2008 RHG & Company, Inc., dba Vital Nutrients [ARCHIVED] New England District Office New Drug/Labeling/False & Misleading Claims/Misbranded N/A *
November 17, 2008 Dabruzzi's Italian Foods, Inc. [ARCHIVED] Minneapolis District Office Food Labeling/False & Misleading/Misbranded N/A *
November 14, 2008 Eagle Parts and Products [ARCHIVED] Atlanta District Office CGMP/QSR/Medical Devices/Adulterated N/A *
November 13, 2008 Lam, Fred M.D. [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) N/A *
November 13, 2008 Artisan Specialty Foods [ARCHIVED] Chicago District Office Seafood HACCP N/A *
November 13, 2008 Rezai, Ali R, M.D [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
November 13, 2008 Saudek, Christopher D. MD [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *



 

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