• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail
-
 

2004 Warning Letters

-

Recently Posted | 2014 | 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

 
Letter Issue Date Company Name Issuing Office Subject Close Out Date
May 13, 2004 Shoemaker, Ritchie C., M.D. [ARCHIVED] Center for Biologics Evaluation and Research Clinical Investigator N/A *
May 13, 2004 HBX, Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Lacks Approved New Drug Application/Labeling/Misbranded N/A *
May 13, 2004 American Medical Specialties, Inc. [ARCHIVED] Florida District Office Quality System Regulation/Adulterated N/A *
May 12, 2004 California Shellfish Company, Inc. [ARCHIVED] San Francisco District Office Seafood HACCP/Adulterated N/A *
May 12, 2004 Efoora, Inc. [ARCHIVED] Chicago District Office Quality System Regulation/Adulterated N/A *
May 12, 2004 World Variety Produce, Inc. [ARCHIVED] Los Angeles District Office Food Labeling/Misbranded N/A *
May 12, 2004 The Chin-Up Strip [ARCHIVED] Center for Devices and Radiological Health Lacks Premarket Approval/Adulterated N/A *
May 11, 2004 Nipro Diabetes Systems, Inc. [ARCHIVED] Florida District Office Quality System Regulation/Adulterated N/A *
May 11, 2004 Baxter Healthcare Corporation [ARCHIVED] Center for Biologics Evaluation and Research Promotional Claims/Misbranded N/A *
May 11, 2004 Garden of Life, Inc. [ARCHIVED] Florida District Office New Drug, Unapproved N/A *
May 10, 2004 Eaker Dairy [ARCHIVED] Atlanta District Office Illegal Drug Residue, Animal Tissue/Adulterated N/A *
May 10, 2004 Beauty Supply [ARCHIVED] Baltimore District Office Contact Lenses/Labeling/Adulterated/Misbranded N/A *
May 07, 2004 Our Lady of the Lake Hospital, Inc. [ARCHIVED] New Orleans District Office GMP for Blood & Blood Components/Adulterated N/A *
May 07, 2004 Colema Boards of California [ARCHIVED] Center for Devices and Radiological Health Lacks Premarket Approval/Gastroenterology-Urology Devices/Misbranded N/A *
May 07, 2004 Blind Industries and Services of Maryland [ARCHIVED] Baltimore District Office Lacks Premarket Approval/QSR/Adulterated/Misbranded N/A *
May 07, 2004 Tony's Smokehouse & Cannery, Inc. [ARCHIVED] Seattle District Office Seafood HACCP/Adulterated N/A *
May 07, 2004 Stormy Seas Seafood [ARCHIVED] Atlanta District Office Seafood HACCP/Adulterated N/A *
May 07, 2004 Tianshi Health Products, Inc., USA [ARCHIVED] Seattle District Office Lacks Premarket Approval/Adulterated/Misbranded N/A *
May 07, 2004 One Way International, Inc. [ARCHIVED] Florida District Office Seafood HACCP/Adulterated N/A *
May 06, 2004 Thomas, Allan Seattle District Office Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated N/A *



-
 

Contact FDA

ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857
-
-
-
-