• 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
-
 

2005 Warning Letters

-

Recently Posted | 2017 | 2016 | 2015 | 2014 | 2013 | 2012

Archived Warning Letters: 2011 | 2010 | 2009 | 2008 | 2007 | 2006 | 2005

Tobacco Retailer Warning Letters

 

-

* 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
07/29/2005 ElderTech Solutions, LLC [ARCHIVED] Seattle District Office Current Good Manufacturing Practices Requirements for Medical Devices/Adulterated N/A *
07/29/2005 Access Genetics [ARCHIVED] Center for Devices and Radiological Health Lacks Premarket Notification Approval/Adulterated/Misbranded N/A *
07/27/2005 Beam of Light Technologies, Inc. [ARCHIVED] Center for Devices and Radiological Health Laser Product Performance Standard/Labeling N/A *
07/27/2005 Superior Rehab Technology, Inc. [ARCHIVED] Dallas District Office Current Good Manufacturing Practice/Adulterated/Misbranded N/A *
07/26/2005 Maria Medeiros Dairy [ARCHIVED] San Francisco District Office Illegal Drug Residue /Adulterated N/A *
07/25/2005 Morris Veterinary Center, PSC [ARCHIVED] Minneapolis District Office Illegal Drug Residue N/A *
07/25/2005 Le Gourmet Lorrain, Inc. [ARCHIVED] Baltimore District Office Food Labeling/Misbranded N/A *
07/22/2005 Merck & Company, Inc. [ARCHIVED] Office of Enforcement Biologics License/Adulterated N/A *
07/21/2005 New England Marketers, Inc. dba Yankee Specialty Foods [ARCHIVED] New England District Office Seafood HACCP/Adulterated N/A *
07/21/2005 ACS Dobfar [ARCHIVED] Center for Drug Evaluation and Research Current Good Manufacturing Practice Regulation/Adulterated N/A *
07/21/2005 MJM International Corporation [ARCHIVED] Dallas District Office CGMP/QSR/Lacks Premarket Approval Application/Medical Device Reporting Regulation N/A *
07/19/2005 Pacific Northwest Best Fish Company [ARCHIVED] Seattle District Office Seafood HACCP/Adulterated N/A *
07/19/2005 SenoRx, Inc. [ARCHIVED] Los Angeles District Office CGMP Requirements for Medical Devices/Adulterated N/A *
07/19/2005 Uroplasty, Inc. [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
07/19/2005 Beck Network, Inc. [ARCHIVED] New Orleans District Office Promotional Claims False & Misleading/New Drugs N/A *
07/18/2005 Mercy Health System of Kansas, Inc. [ARCHIVED] Kansas City District Office Current Good Manufacturing Practices for Blood and Blood Components N/A *
07/18/2005 American Medical Specialties, Inc. [ARCHIVED] Florida District Office Quality System Regulation for Medical Devices/Adulterated/Misbranded N/A *
07/13/2005 Hitachi Medical Systems America, Inc. [ARCHIVED] Cincinnati District Office Medical Device Reporting (MDR) Regulation Misbranded/Adulterated N/A *
07/11/2005 Cape Drugs [ARCHIVED] Center for Drug Evaluation and Research Pharmacy Compounding/New Drug/Misbranded N/A *
07/08/2005 Holmes By-Products Company, Inc. [ARCHIVED] Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded N/A *
07/07/2005 Medical Science Products, Inc. [ARCHIVED] Cincinnati District Office Quality System Reguation/Adulterated N/A *
07/07/2005 Newport Seafoods Inc. [ARCHIVED] Seattle District Office Seafood HACCP/Adulterated N/A *
07/06/2005 Smith Dairy [ARCHIVED] New Orleans District Office Illegal Drug Residue /Adulterated N/A *
07/06/2005 Mark A. Frankle, M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
07/06/2005 Mark A. Mighell, M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
07/06/2005 Donald Pope Veal Farm [ARCHIVED] Minneapolis District Office Illegal Drug Residue N/A *
07/06/2005 Orthometrix, Inc. [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
07/01/2005 Litron Laboratories, Ltd [ARCHIVED] Center for Drug Evaluation and Research Good Laboratory Practice (GLP) N/A *
07/01/2005 Cytogen Corporation [ARCHIVED] Center for Drug Evaluation and Research Labeling/Promotional Claims False & Misleading/Misbranded N/A *
07/01/2005 Blake Street Manufacturing, LLC [ARCHIVED] Denver District Office Food Labeling Misbranded N/A *
06/30/2005 Global Manufacturing & Engineering, LLC [ARCHIVED] New Orleans District Office Current Good Manufacturing Practice/Adulterated N/A *
06/29/2005 Con-Med Corporation [ARCHIVED] Florida District Office Current Good Manuafacturing Practice for Medical Devices/Adulterated/Misbranded N/A *
06/29/2005 CrestLab Inc. [ARCHIVED] Detroit District Office Current Good Manufacturing Practice/Adulterated N/A *
06/28/2005 Kabobs, Inc. [ARCHIVED] Atlanta District Office Seafood HACCP/Adulterated N/A *
06/28/2005 Bimeda MTC Animal Health Inc. [ARCHIVED] Center for Veterinary Medicine Current Good Manufacturing Practice Regulation/Adulterated N/A *
06/28/2005 MedTec Inc [ARCHIVED] Kansas City District Office QSR/Medical Devices/Adulterated N/A *
06/27/2005 Homen Dairy Farms, LP [ARCHIVED] San Francisco District Office Illegal Drug Residue N/A *
06/24/2005 Greer Laboratories, Inc. [ARCHIVED] Office of Enforcement CGMP for Finished Pharmaceutical N/A *
06/24/2005 Georgia Biomedical, Inc. [ARCHIVED] Atlanta District Office Quality System Reguation/Adulterated N/A *
06/23/2005 Khoury, Michael MD [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
06/23/2005 Lee Medical International, Inc. [ARCHIVED] New Orleans District Office CGMP for Medical Devices/QSR/Adulterated/Misbranded N/A *
06/23/2005 St. John Hospital IRB [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) N/A *
06/22/2005 Customed, Inc. [ARCHIVED] San Juan District Office CGMP for Medical Devices/QS/Adulterated N/A *
06/22/2005 Certified Natural Laboratories, Inc. [ARCHIVED] Kansas City District Office Dietary Supplements/Labeling/Misbranded N/A *
06/21/2005 Custom Ultrasonics, Inc. [ARCHIVED] Seattle District Office Current Good Manufacturing Practice Regulation/Adulterated N/A *
06/21/2005 MedImmune Vaccines, Inc. [ARCHIVED] Center for Biologics Evaluation and Research Labeling/Promotional Claims False & Misleading/Misbranded N/A *
06/21/2005 Lake Erie Medical and Surgical, Inc. [ARCHIVED] Detroit District Office Current Good Mfg Practice Regulation/Adulterated/Misbranded N/A *
06/20/2005 Food With Care Inc. [ARCHIVED] Florida District Office Seafood HACCP N/A *
06/17/2005 Pragmatic Materials, Inc. [ARCHIVED] Cincinnati District Office Active Pharmaceutical Ingredient/Adulterated N/A *
06/17/2005 Chickering, Arthur H III [ARCHIVED] New England District Office Adulterated Animal Drugs/Misbranded N/A *

-
 

Contact FDA

ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857
-
-
-
-