2004 Warning Letters

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Warning Letters issued in 2004

 

* 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 04, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
August 04, 2004	Sun Valley Juice Company	Seattle District Office	Juice HACCP	N/A *
August 04, 2004	DIP Seafood Mudbugs	New Orleans District Office	Seafood HACCP/Adulterated	N/A *
August 03, 2004	Ola Olsen Eftf. A/S	Center for Devices and Radiological Health	GMP for Medical Devices/QSR/Adulterated	N/A *
August 03, 2004	Bigmar-Bioren SA	Center for Drug Evaluation and Research	Current Good Mfg Practice Regulations/Adulterated	N/A *
August 03, 2004	Piedmont Hospital, Inc.	Atlanta District Office	Current Good Manufacturing Practices for Blood & Components/Adulterated	N/A *
August 02, 2004	Johnson, Miers, M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
August 02, 2004	SinTea Biotech S.p.A	Center for Devices and Radiological Health	Quality System Regulation/Adulterated	N/A *
July 30, 2004	Medline Industries, Inc.	Dallas District Office	CGMP Requirements of the Quality System Regulations/Adulterated	N/A *
July 30, 2004	Kim, Hyun S. (Kevin), M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
July 30, 2004	Jeffrey's Seafood	Atlanta District Office	Seafood HACCP	N/A *
July 29, 2004	A-1 Sandwich Wholesale Co.	San Francisco District Office	Seafood HACCP/Adulterated	N/A *
July 29, 2004	Jacobs Ranch L.L.C.	Dallas District Office	Illegal Drug Residue, Animal Tissue/Adulterated	N/A *
July 29, 2004	Nottenkamper, Joe	Dallas District Office	Illegal Drug Residue, Animal Tissue/Adulterated	N/A *
July 29, 2004	Stoll Farms, Inc.	Cincinnati District Office	Illegal Drug Residue, Animal Tissue/Adulterated	N/A *
July 28, 2004	Haifa Smoked Fish, Inc.	New York District Office	Seafood HACCP/Adulterated	N/A *
July 28, 2004	First Quality Hygenics, Inc.	Philadelphia District Office	CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated	N/A *
July 28, 2004	Mar, Timothy P., M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
July 27, 2004	Levittown Fish Market	Florida District Office	Seafood HACCP	N/A *
July 27, 2004	Warehouse Food Group, LLC	New Orleans District Office	Seafood HACCP/Adulterated	N/A *
July 26, 2004	Toledo, Jose Gregorio	San Juan District Office	Illegal Drug Residue, Animal Tissue/Adulterated	N/A *

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