2005 Warning Letters

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Warning Letters issued in 2005

 

* 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 February 02, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
September 13, 2005	A & H Farms	Atlanta District Office	Illegal Drug Residue	N/A *
September 09, 2005	Ada Veterinary Clinic, Inc.	Dallas District Office	Illegal Drug Residue /Adulterated	N/A *
September 08, 2005	Seattle Fish Company, Inc.	Kansas City District Office	Seafood HACCP/Adulterated	N/A *
September 07, 2005	Electro Medical, Inc.	Dallas District Office	Current Good Manufacturing Practice/Adulterated	N/A *
September 07, 2005	Parker, Norva R	Dallas District Office	Current Good Manufacturing Practice Regulation/Adulterated	N/A *
September 07, 2005	Xtreme Design, Inc.	Minneapolis District Office	Lacks New Animal Drug Application	N/A *
September 06, 2005	Endurance Products Company, Inc.	Seattle District Office	Promotional Claims False & Misleading/New Drugs	N/A *
September 01, 2005	Sunburst Trout Company, LLC	Atlanta District Office	Seafood HACCP/Adulterated	N/A *
August 31, 2005	Octapharma USA, Inc.	Center for Biologics Evaluation and Research	Labeling/Promotional Claims False & Misleading/Misbranded	N/A *
August 31, 2005	Providence Dairy	Denver District Office	Illegal Drug Residue /Adulterated	N/A *
August 31, 2005	Mackie International, Inc.	Los Angeles District Office	False & Misleading Claims/Misbranded	N/A *
August 30, 2005	Ulrich GmbH & Co. KG	Center for Devices and Radiological Health	Current Good Manufacturing Practice/adulterated/misbranded	N/A *
August 30, 2005	Beverly Hills Prostetics Orthotics, Inc.	Los Angeles District Office	Current Good Manufacturing Practice/Adulterated	N/A *
August 26, 2005	Tepnel Diagnostics Ltd.	Center for Devices and Radiological Health	Lacks Premarket Approval Application Adulterated	N/A *
August 25, 2005	Alpha Omega Manufacturing, Inc.	Dallas District Office	Current Good Manufacturing Practice Regulation/Adulterated	N/A *
August 25, 2005	Bowerman, Freddie J. & Letitia	Dallas District Office	Illegal Drug Residue /Adulterated	N/A *
August 25, 2005	Southern Implants, LLC	Center for Devices and Radiological Health	Current Good Manufacturing Practice Regulation/Adulterated	N/A *
August 25, 2005	A Perfect Food Company, LLC	Florida District Office	Promotional Claims/New Drug/Misbranded	N/A *
August 25, 2005	Efoora, Inc.	Center for Biologics Evaluation and Research	Sponsor/Monitor/Contract Research Organization	N/A *
August 25, 2005	Saliva Diagnostic Systems, Inc.	Center for Biologics Evaluation and Research	Sponsor/Monitor/Contract Research Organization	N/A *

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