2004 Warning Letters

Recently Posted | 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
August 31, 2004	Midwest Heart Foundation	Center for Devices and Radiological Health	Institutional Review Board	N/A *
August 31, 2004	www.bellezaintegral.com	Center for Biologics Evaluation and Research	Unapproved New Drug/Lacks New Drug Application	N/A *
August 31, 2004	Belleza Integral C.A.	Center for Biologics Evaluation and Research	Unapproved New Drug/Lacks New Drug Application	N/A *
August 30, 2004	Henrico Doctor's Hospital IRB	Center for Devices and Radiological Health	Institutional Review Board	N/A *
August 30, 2004	Medical Device Resource Corporation	San Francisco District Office	GMP for Medical Devices/QSR/Adulterated	N/A *
August 30, 2004	Ly, David S.	San Francisco District Office	Seafood HACCP/Adulterated	N/A *
August 27, 2004	Washington Township Hospital	San Francisco District Office	Mammography Quality Standards	N/A *
August 27, 2004	Remington Medical Inc	Atlanta District Office	QSR/Medical Devices/Adulterated	N/A *
August 27, 2004	Center for Comprehensive Medicine	San Francisco District Office	Mammography Quality Standards	N/A *
August 26, 2004	American Fruit Distributors, Inc.	New England District Office	Refusal to Permit Entry/Inspection	N/A *
August 26, 2004	Flora, Inc.	Seattle District Office	Unapproved New Drug/Misbranded	N/A *
August 25, 2004	La Vencedora Products, Inc.	Los Angeles District Office	Food Labeling/Misbranded	N/A *
August 25, 2004	Two Brothers Organics, Inc.	Denver District Office	Juice HACCP/Adulterated	N/A *
August 25, 2004	Guaranteed Total Vending	New Orleans District Office	Seafood HACCP/Adulterated	N/A *
August 24, 2004	ICH Group, LLC dba Sushi Chef	San Francisco District Office	Seafood HACCP/Adulterated	N/A *
August 23, 2004	Medical Industries America, Inc.	Kansas City District Office	CGMP Requirements of the Quality System Regulations/Adulterated	N/A *
August 20, 2004	Medical Energy, Inc.	Florida District Office	Quality System Regulation for Medical Devices/Adulterated	N/A *
August 19, 2004	Poseidon Seafood, Inc.	Los Angeles District Office	Seafood HACCP	N/A *
August 19, 2004	Window Rock Enterprises, Inc.	Los Angeles District Office	Promotional Claims/False & Misleading/Misbranded	N/A *
August 18, 2004	Natureplex, LLC	New Orleans District Office	Current Good Mfg Practice Regulation/Adulterated/Misbranded	N/A *
August 18, 2004	Impro Products Inc.	Kansas City District Office	Unapproved New Animal Drug/Adulterated	N/A *
August 17, 2004	Steridyne Industries LLC	Florida District Office	CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation	N/A *
August 17, 2004	Fulton Seafood, Inc.	Dallas District Office	Seafood HACCP/Adulterated	N/A *
August 16, 2004	Rejuvenu International, Ltd.	Center for Devices and Radiological Health	Quality System Regulation/Adulterated	N/A *
August 16, 2004	Aventis Pasteur SA	Office of Enforcement	CGMP	N/A *
August 16, 2004	Auburn University	Center for Veterinary Medicine	Investigational New Animal Drug Sponsor	N/A *
August 16, 2004	LifeScan/DDI	Center for Devices and Radiological Health	GMP for Medical Devices/QSR/Adulterated	N/A *
August 16, 2004	Extended Care Air Therapy Systems, Inc.	Cincinnati District Office	Quality System Regulation/Adulterated	N/A *
August 13, 2004	VIRALSOL	Center for Food Safety and Applied Nutrition	Unapproved New Drug	N/A *
August 12, 2004	Westmed de Mexico, S.A.	Center for Devices and Radiological Health	GMP for Medical Devices/QSR/Adulterated	N/A *
August 12, 2004	Paul's Fruit Market, Inc.	Cincinnati District Office	Juice HACCP	N/A *
August 11, 2004	Louisiana Fine Foods, Inc.	Dallas District Office	Seafood HACCP/Adulterated	N/A *
August 10, 2004	J Troost Dairy	San Francisco District Office	Illegal Drug Residue, Animal Tissue/Adulterated	N/A *
August 09, 2004	Sarraga, Diaz & Asociados, Inc.	San Juan District Office	Food Labeling/Adulterated	N/A *
August 09, 2004	Barney's Weir Cove Bakery	Baltimore District Office	CGMP/Deviations/Adulterated	N/A *
August 09, 2004	genX International Inc.	New England District Office	QSR/Medical Devices/Adulterated	N/A *
August 09, 2004	Novo Nordisk Pharmaceuticals, Inc.	Center for Biologics Evaluation and Research	Promotional Claims/False & Misleading	N/A *
August 06, 2004	Crystal Laboratory, Inc.	Office of Enforcement	Biological Product Establishment Standard/Adulterated	N/A *
August 06, 2004	The Veterinary Pharmacy, Inc.	Dallas District Office	Extralabel Drug Use In Animals	N/A *
August 05, 2004	United Cooperative Farmers, Inc.	New York District Office	CGMP/Medicated Feeds/Adulterated	N/A *
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 *

• Previous
• 1
• 2
• 3
• 4
• 5
• 6
• 7
• 8
• 9
• 10
• 11
• 12
• 13
• 14
• 15
• Next