2006 Warning Letters

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Warning Letters issued in 2006

 

* 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 15, 2006	Dialysis Services, Inc.	New Orleans District Office	CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated	N/A *
September 14, 2006	Zaharowitz, Herman, M.D.	Center for Drug Evaluation and Research	Clinical Investigator	N/A *
September 12, 2006	Matheson Tri-Gas, Inc.	Dallas District Office	CGMP for Finished Pharmaceuticals/Adulterated	N/A *
September 11, 2006	Patriot Foods LLC	Florida District Office	Seafood HACCP/Adulterated	N/A *
September 08, 2006	Zeis, Fred J	Minneapolis District Office	Illegal Drug Residue /Adulterated	N/A *
September 08, 2006	Hawkins, Inc.	Minneapolis District Office	CGMP Active Pharmaceutical Ingredient	N/A *
September 07, 2006	Boston Salads & Provisions Co., Inc.	New England District Office	Seafood HACCP/Adulterated	N/A *
September 07, 2006	Ramona's Mexican Food Products, Inc.	Los Angeles District Office	Food / Insanitary Conditions	N/A *
September 06, 2006	ALK-Abello, Inc.	Center for Biologics Evaluation and Research	Promotional Claims False & Misleading/Misbranded	N/A *
September 05, 2006	Carribean Conch, Inc.	Florida District Office	Adulterated Seafood HACCP	N/A *
September 05, 2006	Smith Medical Critical Care, Inc.	Cincinnati District Office	CGMP for Medical Devices/Adulterated	N/A *
September 05, 2006	Biolase Technology, Inc.	Los Angeles District Office	Current Good Manufacturing Practices Requirements for Medical Devices/Adulterated	N/A *
August 31, 2006	Moon Glow Dairy	San Francisco District Office	Illegal Drug Residue /Adulterated	N/A *
August 31, 2006	Grupo Gloria/Suiza Dairy	San Juan District Office	Food Labeling/Misbranded	N/A *
August 31, 2006	Terumo Cardiovascular Systems	Detroit District Office	Quality System Regulations for Medical Device Reporting/Misbranded	N/A *
August 31, 2006	Frye Health Systems, Inc.	Dallas District Office	Current Good Manufacturing Practice/Adulterated	N/A *
August 30, 2006	Oregon Ocean Seafoods	Seattle District Office	Seafood HACCP/Adulterated	N/A *
August 29, 2006	Medtronic, Inc.	Minneapolis District Office	CGMP for Medical Devices/Adulterated	N/A *
August 29, 2006	LGS Technologies, LP	Dallas District Office	CGMP for Medical Devices/Adulterated	N/A *
August 28, 2006	John Potter Farm, LLC	New England District Office	Illegal Drug Residue	N/A *

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