• 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
-
 

2007 Warning Letters

-

Recently Posted | 2017 | 2016 | 2015 | 2014 | 2013 | 2012 | 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
September 21, 2007 Ben J. Weaver New York District Office Illegal Drug Residue N/A *
September 20, 2007 Toms, Matthew Baltimore District Office Illegal Drug Residue N/A *
September 19, 2007 Zinnanti Surgical Design, LLC [ARCHIVED] Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated N/A *
September 19, 2007 Genzyme Corporation [ARCHIVED] Center for Biologics Evaluation and Research CGMP Deviations N/A *
September 18, 2007 Amato, Robert J., D.O. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
September 14, 2007 Procter and Gamble [ARCHIVED] Cincinnati District Office Labeling/OTC Drugs N/A *
September 11, 2007 Tembec, Inc. [ARCHIVED] Cincinnati District Office Food Additive/Adulterated/Misbranded N/A *
September 11, 2007 Universal Enterprises, Inc. [ARCHIVED] San Francisco District Office Interstate Conveyance Sanitation/Control of Communicable Disease N/A *
September 11, 2007 American Nutrition, Inc [ARCHIVED] Denver District Office Animal Food/Misbranded/Labeling N/A *
September 10, 2007 Murvest, Inc. [ARCHIVED] Florida District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
September 07, 2007 North Coast Medical Inc. [ARCHIVED] San Francisco District Office CGMP/QSR/Medical Devices/Adulterated N/A *
September 06, 2007 Danmar Product, Inc. [ARCHIVED] Detroit District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
September 06, 2007 Kunshan Chemical and Pharmaceutical Co., Ltd. [ARCHIVED] Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/Deviations/Adulterated N/A *
September 04, 2007 Sorenson Medical, Inc. [ARCHIVED] Denver District Office CGMP For Manufacturing, Packing, Storage or Installation/Adulterated/Misbranded N/A *
September 04, 2007 Tobler, William D., MD [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
August 30, 2007 Millner Trading Company, Inc. [ARCHIVED] Philadelphia District Office Acidified Foods/Emergency Permit Control/Adulterated/Misbranded N/A *
August 30, 2007 Boston Scientific Cardiovascular [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
August 30, 2007 Melanocorp, Inc. [ARCHIVED] New Orleans District Office Drug/Lacks Approved Application N/A *
August 29, 2007 Ochsner Clinic Foundation [ARCHIVED] New Orleans District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products N/A *
August 29, 2007 Oberlander Baking Co. [ARCHIVED] Center for Food Safety and Applied Nutrition False & Misleading Claims/Misbranded N/A *
August 29, 2007 All Medicus Co. Ltd [ARCHIVED] Center for Devices and Radiological Health CGMP for Medical Devices/Adulterated N/A *
August 29, 2007 Fish Busterz L.L.C [ARCHIVED] Florida District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
August 28, 2007 Chris & Tracey Elbe Dairy Farm Minneapolis District Office Illegal Drug Residue N/A *
August 28, 2007 Leiner Health Products, LLC [ARCHIVED] Atlanta District Office CGMP for Finished Pharmaceuticals/Deviations/Adulterated N/A *
August 27, 2007 Sea Farms Incorporated [ARCHIVED] Baltimore District Office Seafood HACCP/Adulterated N/A *
August 27, 2007 Wheaton Beauty Supply [ARCHIVED] Baltimore District Office Device/Lacks Approved/Misbranded N/A *
August 23, 2007 Potty MD, LLC [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
August 22, 2007 F. H. G. Corporation [ARCHIVED] Florida District Office Promotional Claims/Misbranded N/A *
August 21, 2007 Hyson USA Inc [ARCHIVED] Chicago District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
August 21, 2007 Beef Northwest Feeders, LLC Seattle District Office Illegal Drug Residue N/A *
August 20, 2007 Vigor Nutriceutical Healthcare, Inc. [ARCHIVED] Minneapolis District Office Misbranded/Labeling/Unauthorized Health Claims N/A *
August 17, 2007 American Mobile Medical Surgical Group Inc [ARCHIVED] New Jersey District Office Mammography Quality Standards Act N/A *
August 17, 2007 Hidden Valley Mills [ARCHIVED] Los Angeles District Office Juice HACCP/Adulterated N/A *
August 17, 2007 Hain Celestial Group, Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Dietary Supplement/Adulterated N/A *
August 16, 2007 Blue Heron Bakery, Inc. [ARCHIVED] Seattle District Office False & Misleading Claims/Misbranded N/A *
August 15, 2007 Spineology, Inc. [ARCHIVED] Center for Devices and Radiological Health Device/Lacks Premarket Approval Application/Adulterated/Misbranded N/A *
August 13, 2007 World Sushi Express, Inc. [ARCHIVED] Los Angeles District Office Seafood HACCP/Adulterated N/A *
August 10, 2007 Mark Nolt Farm d/b/a Nature's Sunlight Farm [ARCHIVED] Philadelphia District Office Interstate Commerce/Misbranded N/A *
August 10, 2007 Belvin Seafood Corporation [ARCHIVED] Baltimore District Office Seafood HACCP/Adulterated N/A *
August 09, 2007 Arizona Dairy Company, LLP Los Angeles District Office Illegal Drug Residue N/A *
August 08, 2007 Novis PR dba Kramer-Novis [ARCHIVED] San Juan District Office OTC Drug Products/Dietary Supplements/Misbranded N/A *
August 08, 2007 Swanson Health Products, Inc. [ARCHIVED] Minneapolis District Office Dietary Supplements N/A *
August 07, 2007 Sunburst Biorganics [ARCHIVED] New York District Office Dietary Supplements N/A *
August 02, 2007 Cook's Seafood Company [ARCHIVED] Baltimore District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
August 01, 2007 Sunoptic Technologies, LLC [ARCHIVED] Florida District Office CGMP for Medical Devices/Adulterated N/A *
July 31, 2007 Genaros Seafood, Inc. [ARCHIVED] Florida District Office Seafood HACCP/Adulterated/Misbranded N/A *
July 31, 2007 Riverfront Fish Market [ARCHIVED] Dallas District Office Seafood HACCP N/A *
July 31, 2007 Bay Valley Foods, LLC [ARCHIVED] Philadelphia District Office Acidified Foods/Adulterated N/A *
July 30, 2007 Pulse Biomedical, Inc. [ARCHIVED] Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated N/A *
July 30, 2007 GMI European Food Distributors Inc. [ARCHIVED] New England District Office CGMP for Foods/Seafood HACCP/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
-
-
-
-