2003 Warning Letters

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Warning Letters issued in 2003

 

* 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 May 05, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
August 13, 2003	Cadio Design Pty. Ltd.	Center for Devices and Radiological Health	Medical Device/CGMP Requirements of Quality System Regulation	N/A *
August 11, 2003	Wright Medical Technology, Inc.	New Orleans District Office	Quality System Regulation/Adulterated	N/A *
August 11, 2003	Chez Francois Seafood	New Orleans District Office	Seafood HACCP/Adulterated	N/A *
August 11, 2003	ElectraMold Inc.	Cincinnati District Office	Quality System Regulations	N/A *
August 08, 2003	Pacific Seafood	San Francisco District Office	Seafood HACCP/Adulterated	N/A *
August 08, 2003	Scarrow Dairy	Seattle District Office	Illegal Drug Residue Animal Tissue/Adulterated	N/A *
August 08, 2003	Winona Memorial Hospital	Detroit District Office	Mammography Quality Standards	N/A *
August 08, 2003	Philips Medical Systems, Inc	Center for Devices and Radiological Health	Device Labeling/Promotional Claims/Misbranded	N/A *
August 08, 2003	Mercy Medical Center - Sioux City	Kansas City District Office	GMP for Blood and Bood Components/Adverse Reaction Reports	N/A *
August 07, 2003	Pezzolo Seafood	San Francisco District Office	Seafood HACCP/Adulterated	N/A *
August 07, 2003	Forest Laboratories, Inc.	Cincinnati District Office	New Drug/GMP for Finished Pharmaceuticals/GMP for Mfr, Processing, Holding Drugs/Adulterated	N/A *
August 07, 2003	Kilgore Veterinary Associates, Inc.	Dallas District Office	Unapproved New Animal Drugs/Extralabel Drug Use/Adulterated	N/A *
August 05, 2003	Image Analysis, Inc.	Cincinnati District Office	Device Labeling/Quality System Regulation/Misbranded/Adulterated	N/A *
August 05, 2003	Enviropak LLC	New Orleans District Office	Quality System Regulation for Medical Devices/Adulterated	N/A *
August 05, 2003	Wilson C. Milius, Inc.	Kansas City District Office	Illegal Drug Residue, Animal Tissue/Adulterated	N/A *
August 05, 2003	LA Hearne Company	San Francisco District Office	Good Manufacturing Practice for Medicated Feeds/Adulterated	N/A *
August 05, 2003	Mid-Florida Bakeries, LLC	Florida District Office	Good Manufacturing Practice Regulations for Human Foods/adultered	N/A *
August 04, 2003	J & R Feed Services, Inc.	New Orleans District Office	Good Manufacturing Practice for Medicated Feeds/Adulterated	N/A *
August 01, 2003	The First Years, Inc.	New England District Office	Lacks Premarket Notification/Adulterated	N/A *
August 01, 2003	Keitsen Technology (Shenzhen) Co., Ltd.	Center for Devices and Radiological Health	Performance Standards for Microwave & Radio Frequency Emitting Products	N/A *

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