• 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

Section Contents Menu

Enforcement Actions

2008 Warning Letters

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

Warning Letters issued in 2008

 

* 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 02, 2008 Immucor, Inc. Office of Enforcement CGMP Deviations N/A *
May 01, 2008 Stihler, Alex Center for Devices and Radiological Health Investigational Device Exemptions(Clinical Investigator)/Adulterated N/A *
May 01, 2008 Golzar Nasim, MD Center for Drug Evaluation and Research Clinical Investigator N/A *
April 30, 2008 Medical Solutions International, Inc. Kansas City District Office CGMP/QSR/Medical Devices/Adulterated N/A *
April 28, 2008 Merck & Company, Inc. Office of Enforcement CGMP Manufacture of Licensed Biological Vaccine Products/Bulk Drug Substances/Components N/A *
April 25, 2008 Stryer Biotech New England District Office CGMP/QSR/Medical Devices/Adulterated N/A *
April 24, 2008 Behavioral Therapeutics, LLC. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
April 23, 2008 Heartsine Technologies, LTD Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
April 23, 2008 Polymer Technologies Systems, Inc. Detroit District Office CGMP/QSR/Medical Devices/Adulterated N/A *
April 23, 2008 Nauta, Haring J.W., MD Center for Devices and Radiological Health Clinical Investigator N/A *
April 23, 2008 National Biological Corporation Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated N/A *
April 22, 2008 Care Rehab and Orthopaedic Products, Inc. Baltimore District Office CGMP/QSR/Medical Devices/Adulterated N/A *
April 22, 2008 Sea World, Inc. San Juan District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
April 21, 2008 Changzhou SPL Company, Ltd ( a/k/a "Kaipu") Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredients/Adulterated N/A *
April 21, 2008 Gordon, Stephen W., MD Center for Devices and Radiological Health Clinical Investigator N/A *
April 19, 2008 A.B. Cole Dairy Farm Philadelphia District Office Illegal Drug Residue N/A *
April 18, 2008 Classic Catering & Commissary Corp. New York District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
April 17, 2008 Gemtronics Inc Atlanta District Office New Drug/Labeling/False & Misleading Claims N/A *
April 15, 2008 Blood Center of New Jersey New Jersey District Office Blood Products/Adulterated N/A *
April 15, 2008 L. Neil Jones Food Company dba Northwest Packing Company Seattle District Office Seafood HACCP/CGMP for Foods/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
-