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
April 21, 2006	Smiling Hill Farm Inc	New England District Office	Juice HACCP	N/A *
April 20, 2006	Kingston-Miami Trading Company	Florida District Office	Current Good Manufacturing Practice Requirements for Foods/Seafood HACCP/Adulterated	N/A *
April 20, 2006	Advanced Imaging Research, Inc	Cincinnati District Office	Quality System Regulation/Medical Device Reporting/Adulterated/Misbranded	N/A *
April 18, 2006	Twin Tails Seafood Corp.	Florida District Office	Seafood HACCP/Adulterated	N/A *
April 14, 2006	Petrie Farms	New York District Office	Illegal Drug Residue	N/A *
April 13, 2006	Resonance Technology, Inc.	Los Angeles District Office	Current Good Manufacturing Practice Regulation/Adulterated	N/A *
April 13, 2006	Japanese Food Express, Inc.	Detroit District Office	Seafood HACCP/Adulterated	N/A *
April 13, 2006	Hardie Farms, Inc.	New York District Office	Illegal Drug Residue	N/A *
April 12, 2006	Schell and Kampeter Inc.	Atlanta District Office	Illegal Drug Residue/Adulterated/Misbranded	N/A *
April 11, 2006	Ocean Deep, LLC	Florida District Office	Seafood HACCP/Adulterated	N/A *
April 10, 2006	Neurotone Systems, Inc	Dallas District Office	Current Good Manufacturing Practices Requirements for Medical Devices/Adulterated	N/A *
April 07, 2006	Orthohelix Surgical Designs, Inc	Cincinnati District Office	Qaulity System Regulation/Correction & Removal Regulation/Adulterated/Misbranded	N/A *
April 07, 2006	Cody Laboratories, Inc	Denver District Office	Current Good Manufacturing Practices/Active Pharmaceuticals Ingredient/Adulterated	N/A *
April 07, 2006	Ferno-Washington, Inc	Cincinnati District Office	Current Good Manufacturing Practice/Medical Device Report Regulation/Adulterated	N/A *
April 06, 2006	McAdam Health Enterprises	Seattle District Office	Labeling/Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
April 05, 2006	Bold Coast Smokehouse	New England District Office	CGMP for Foods/Seafood HACCP/Adulterated	N/A *
April 05, 2006	Valentine, Joseph	Philadelphia District Office	Illegal Drug Residue Animal Tissue/Adulterated	N/A *
April 05, 2006	Sam Rust Seafood Inc.	Baltimore District Office	Seafood HACCP/Adulterated	N/A *
April 04, 2006	Centro Estudios Radiologicos - Santurce Medical Mall	San Juan District Office	Mammography Quality Standards Act	N/A *
April 04, 2006	Wilbur Ellis Company	Denver District Office	New Animal Drug/Adulterated	N/A *
April 03, 2006	Royal Crest Dairy, Inc.	Denver District Office	Juice HACCP/Adulterated	N/A *
April 01, 2006	EM Innovations, Inc	Cincinnati District Office	Quality Systems Regulation/Adulterated	N/A *
March 31, 2006	Bonamar Corporation	Florida District Office	Seafood HACCP/Adulterated	N/A *
March 30, 2006	Karina Manufacturing Inc.	San Juan District Office	Food Labeling/Misbranded	N/A *
March 30, 2006	EEMSO, Inc.	Dallas District Office	CGMP for Medical Devices/Medical Device Reporting/Adulterated	N/A *
March 29, 2006	Kickapoo Orchard, Inc	Minneapolis District Office	Juice HACCP/Adulterated	N/A *
March 28, 2006	ASK Foods, Inc	Philadelphia District Office	CGMP for Foods/Seafood HACCP/Adulterated	N/A *
March 27, 2006	Brown, John M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
March 27, 2006	Boman, William	Philadelphia District Office	Illegal Drug Residue	N/A *
March 24, 2006	VaxGen Inc.	Center for Biologics Evaluation and Research	Labeling/False & Misleading Claims/Misbranded	N/A *
March 23, 2006	MNC Pharmaceuticals Group, Inc	Philadelphia District Office	Labeling/Promotional Claims False & Misleading/New Drug/Misbranded	N/A *
March 23, 2006	Royal Foods, Inc.	Minneapolis District Office	Seafood HACCP/Adulterated	N/A *
March 23, 2006	Mr. Fish Seafood	Dallas District Office	Seafood HACCP/Adulterated	N/A *
March 22, 2006	North American Herb & Spice	Chicago District Office	Labeling/Promotional Claims False & Misleading/New Drug	N/A *
March 21, 2006	Ustov, Inc.	San Francisco District Office	Seafood HACCP/Adulterated	N/A *
March 21, 2006	Fenster, Paul M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
March 20, 2006	Southern Tier Plastics Inc	New York District Office	QSR/Medical Devices/Adulterated	N/A *
March 17, 2006	Agile Radiological Technologies, Inc.	Cincinnati District Office	Current Good Manufacturing Practice for Medical Devices/Adulterated	N/A *
March 17, 2006	Pacific Hi-Tak, Inc.	San Francisco District Office	Seafood HACCP/Adulterated	N/A *
March 17, 2006	Sea Breeze Fish Market Inc	New York District Office	CGMP for Foods/Seafood HACCP/Adulterated	N/A *
March 17, 2006	In Vivo Metric Systems Corporation	San Francisco District Office	GMP Requirement/Quality System Regulations/Medical Device Reporting	N/A *
March 17, 2006	Jensen & Pilegard	San Francisco District Office	Current Good Manufacturing Practice for Medicated Feeds/Adulterated	N/A *
March 16, 2006	FRM Chemical, Inc.	Kansas City District Office	CGMP for Finished Pharmaceuticals/Adulterated	N/A *
March 16, 2006	PML Microbiologicals, Inc.	Seattle District Office	Lacks Premarket Approval Application/Adulterated/Misbranded	N/A *
March 16, 2006	Daiei Trading Co., Inc	New York District Office	Seafood HACCP/Adulterated	N/A *
March 15, 2006	B. Braun Medical Inc	Philadelphia District Office	CGMP/Pharmacy Compounding/Insanitary Condition/Adulterated/Misbranded	N/A *
March 15, 2006	Supreme Lobster & Seafood Co.	Chicago District Office	Seafood HACCP/Adulterated	N/A *
March 15, 2006	Ranieri Fine Food Corporation	New York District Office	Seafood HACCP/Adulterated	N/A *
March 15, 2006	Lost Trail Dairy, LLC	Dallas District Office	Illegal Drug Residue /Adulterated	N/A *
March 13, 2006	Global Healing Center	Dallas District Office	Labeling/Promotional Claims False & Misleading/New Drug	N/A *

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