2004 Warning Letters

Recently Posted | 2013 | 2012 | 2011 | 2010 | 2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996 |

Tobacco Retailer Warning Letters

 

Recently Posted | 2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996

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
November 22, 2004	Miracle Fish, Inc.	Florida District Office	Seafood HACCP	N/A *
November 19, 2004	Protherics, Inc.	Center for Biologics Evaluation and Research	Promotional Claims/False & Misleading	N/A *
November 19, 2004	Ortek AG	Center for Devices and Radiological Health	CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated	N/A *
November 19, 2004	Pharmachem Laboratories, Inc.	New Jersey District Office	Dietary Supplement/Labeling/False & Misleading Claims/Misbranded	N/A *
November 19, 2004	Jomara Seafood, Inc.	Florida District Office	Seafood HACCP/Adulterated	N/A *
November 19, 2004	DiGiorgio Corp.	New Jersey District Office	Seafood HACCP/Adulterated	N/A *
November 19, 2004	Ferndale Laboratories, Inc.	Detroit District Office	Lacks Approved New Drug Application/Labeling/Misbranded	N/A *
November 19, 2004	ATF Fitness Products, Inc.	Philadelphia District Office	Dietary Supplement/Labeling/Adulterated	N/A *
November 19, 2004	Osprey Seafood of California, Inc.	San Francisco District Office	Seafood HACCP/Adulterated	N/A *
November 18, 2004	LA Dorada Coral Gables, Inc.	Florida District Office	Seafood HACCP	N/A *
November 18, 2004	Parrish & Heimbecker Limited	Seattle District Office	Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded	N/A *
November 17, 2004	Community Hospital & Rehabilitation Center of Los Gatos	San Francisco District Office	Mammography Quality Standards	N/A *
November 17, 2004	Nuclear Cardio Systems, Inc.	Denver District Office	CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated	N/A *
November 17, 2004	Constantine, Niel T., Ph.D.	Center for Biologics Evaluation and Research	Clinical Investigator	N/A *
November 17, 2004	Pajunk GmbH	Center for Devices and Radiological Health	CGMP for Medical Devices/QSR/Adulterated/Misbranded	N/A *
November 17, 2004	Amsterdam, Daniel, Ph.D.	Center for Biologics Evaluation and Research	Clinical Investigator	N/A *
November 16, 2004	MED-EL ELEKTRO-MEDIZINISCHE GERATE GmbH	Center for Devices and Radiological Health	CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated	N/A *
November 15, 2004	Upscale Foods, Inc.	Minneapolis District Office	Food Labeling/Misbranded	N/A *
November 12, 2004	Clarity, Inc.	New Orleans District Office	CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated	N/A *
November 10, 2004	Alveolus, Inc.	Atlanta District Office	CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated	N/A *

• Previous
• 1
• 2
• 3
• 4
• 5
• 6
• 7
• 8
• 9
• 10
• 11
• 12
• 13
• 14
• 15
• 16
• 17
• 18
• 19
• 20
• 21
• 22
• 23
• 24
• 25
• 26
• 27
• 28
• 29
• 30
• 31
• 32
• 33
• 34
• 35
• 36
• Next