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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2008 Warning Letters

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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
June 17, 2008 Nick & Katie's Inc. [ARCHIVED] New Orleans District Office Seafood/HACCP/CGMP for Foods/Adulterated N/A *
June 16, 2008 HoMedics, Incorporated [ARCHIVED] Detroit District Office CGMP for Medical Devices/QSR/Adulterated/Misbranded N/A *
June 13, 2008 Green's Fresh Fruit Salad Corporation (dba Salad Chef) [ARCHIVED] Seafood HACCP/CGMP for Foods/Adulterated N/A *
June 11, 2008 T.H. Seafood [ARCHIVED] Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
June 11, 2008 Duro-Med Industries [ARCHIVED] Atlanta District Office CGMP/QSR/Medical Devices/Adulterated N/A *
June 11, 2008 Ipswich Shellfish Co., Inc. [ARCHIVED] New England District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
June 10, 2008 Hazenberg Dairy [ARCHIVED] Seattle District Office Illegal Drug Residue N/A *
June 10, 2008 Hontech Foundation for Medical Technology [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated N/A *
June 10, 2008 Reproductive Medicine & Fertility Center of Southern Colorado LLC [ARCHIVED] Denver District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products N/A *
June 09, 2008 New Sun, Inc. [ARCHIVED] Atlanta District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
June 09, 2008 Nutritional Counselors of America [ARCHIVED] New Orleans District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
June 09, 2008 Harris Dairies [ARCHIVED] Dallas District Office Illegal Drug Residue N/A *
June 06, 2008 Ponugoti, Nagarjuna R., M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
June 06, 2008 Chattem, Inc. [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
June 05, 2008 Miller's Bakery, inc. [ARCHIVED] Minneapolis District Office Food Labeling/Misbranded N/A *
June 04, 2008 Kimberly-Clark Corporation [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting N/A *
June 04, 2008 A.P. Bell Fish Company, Inc. [ARCHIVED] Florida District Office Seafood/HACCP/CGMP for Foods/Adulterated N/A *
June 03, 2008 Vitasalus, Inc. [ARCHIVED] Detroit District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
June 03, 2008 Grimm's Stone Crab Inc. [ARCHIVED] Florida District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
June 03, 2008 LeMaitre, George W. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator/Sponsor N/A *



 

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