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

Posted on April 08, 2009

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

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