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

Posted on April 08, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
July 02, 2008	Anika Therapeutics, Inc.	New England District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
July 02, 2008	Full Circle Dairy, LLC	Florida District Office	Illegal Drug Residue	N/A *
June 30, 2008	Travanti Pharma, Inc.	Center for Drug Evaluation and Research	Sponsor-Applicant-Monitor-Clinical Research Organization	N/A *
June 27, 2008	Oncology Tech, LLP	Dallas District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
June 27, 2008	Pescaderia Atlantica, Inc.	San Juan District Office	Seafood HACCP/CGMP for Foods/Adulterated	N/A *
June 25, 2008	I.T. Foods Industries Co., LTD.	Center for Food Safety and Applied Nutrition	Seafood HACCP/CGMP for Foods/Adulterated	N/A *
June 25, 2008	Sauflon Pharmaceuticals, LTD	Center for Devices and Radiological Health	Medical Device Reporting	N/A *
June 25, 2008	IOPI Northwest Company, LLC	Seattle District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
June 25, 2008	Cargill, Inc.	Seattle District Office	CGMP for Medicated Feeds/Adulterated	N/A *
June 25, 2008	Encore Medical, L.P.	New Orleans District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
June 24, 2008	Newman Inc., (dba Medi-Stat)	New Orleans District Office	New Drug/Adulterated/Misbranded	N/A *
June 23, 2008	Mathis Ranch, LLC dba Texas Legend Ranch	Dallas District Office	Illegal Drug Residue	N/A *
June 20, 2008	KeyMed (Medical and Industrial Equipment) Ltd.	Center for Devices and Radiological Health	CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated	N/A *
June 20, 2008	J & S Dairy Farm Inc.	Dallas District Office	Illegal Drug Residue	N/A *
June 19, 2008	Captain Jackie's Seafood, Inc.	New Orleans District Office	Seafood HACCP/CGMP for Foods/Adulterated	N/A *
June 19, 2008	Domina, Gary	New England District Office	Illegal Drug Residue	N/A *
June 19, 2008	Emerson Seafood, Inc.	New York District Office	Seafood HACCP/CGMP for Foods/Adulterated	N/A *
June 19, 2008	Uintah Basin Medical Center	Denver District Office	CGMP for Blood & Blood Components/Adulterated	N/A *
June 17, 2008	Nick & Katie's Inc.	New Orleans District Office	Seafood/HACCP/CGMP for Foods/Adulterated	N/A *
June 16, 2008	HoMedics, Incorporated	Detroit District Office	CGMP for Medical Devices/QSR/Adulterated/Misbranded	N/A *
June 13, 2008	Green's Fresh Fruit Salad Corporation (dba Salad Chef)		Seafood HACCP/CGMP for Foods/Adulterated	N/A *
June 11, 2008	Ipswich Shellfish Co., Inc.	New England District Office	Seafood HACCP/CGMP for Foods/Adulterated	N/A *
June 11, 2008	T.H. Seafood	Seattle District Office	Seafood HACCP/CGMP for Foods/Adulterated	N/A *
June 11, 2008	Duro-Med Industries	Atlanta District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
June 10, 2008	Hontech Foundation for Medical Technology	New England District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
June 10, 2008	Reproductive Medicine & Fertility Center of Southern Colorado LLC	Denver District Office	Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products	N/A *
June 10, 2008	Hazenberg Dairy	Seattle District Office	Illegal Drug Residue	N/A *
June 09, 2008	New Sun, Inc.	Atlanta District Office	DDMAC/Promotional Claims False & Misleading/Misbranded	N/A *
June 09, 2008	Harris Dairies	Dallas District Office	Illegal Drug Residue	N/A *
June 09, 2008	Nutritional Counselors of America	New Orleans District Office	DDMAC/Promotional Claims False & Misleading/Misbranded	N/A *
June 06, 2008	Chattem, Inc.	New Orleans District Office	CGMP/QSR/Medical Devices/Adulterated/Misbranded	N/A *
June 06, 2008	Ponugoti, Nagarjuna R., M.D.	Center for Drug Evaluation and Research	Clinical Investigator	N/A *
June 05, 2008	Miller's Bakery, inc.	Minneapolis District Office	Food Labeling/Misbranded	N/A *
June 04, 2008	A.P. Bell Fish Company, Inc.	Florida District Office	Seafood/HACCP/CGMP for Foods/Adulterated	N/A *
June 04, 2008	Kimberly-Clark Corporation	Center for Devices and Radiological Health	Medical Device Reporting	N/A *
June 03, 2008	Seoul Shopping, Inc	New York District Office	Seafood HACCP/Adulterated	N/A *
June 03, 2008	Grimm's Stone Crab Inc.	Florida District Office	Seafood HACCP/CGMP for Foods/Adulterated	N/A *
June 03, 2008	LeMaitre, George W.	Center for Devices and Radiological Health	Clinical Investigator/Sponsor	N/A *
June 03, 2008	Nutrition 2000	New Orleans District Office	DDMAC/Promotional Claims False & Misleading/Misbranded	N/A *
June 03, 2008	Vitasalus, Inc.	Detroit District Office	DDMAC/Promotional Claims False & Misleading/Misbranded	N/A *
June 03, 2008	Sysco Food Services of Albany, LLC	New York District Office	Seafood HACCP/CGMP for Foods/Adulterated	N/A *
June 03, 2008	Sysco Food Services of Albany, LLC	New York District Office	Seafood HACCP/CGMP for Foods/Adulterated	N/A *
June 02, 2008	Hamlin, Charles M.D.	Center for Devices and Radiological Health	Clinical Investigator/Sponsor	N/A *
June 02, 2008	Institute for Healthy Aging	Florida District Office	DDMAC/Promotional Claims False & Misleading/Misbranded	N/A *
June 02, 2008	NaturesAlternatives.com	Los Angeles District Office	Promotional Claims/False & Misleading	N/A *
June 02, 2008	Rayong Fish Sauce Industry Co., Ltd.	Center for Food Safety and Applied Nutrition	Seafood HACCP/CGMP for Foods/Adulterated	N/A *
June 02, 2008	Fem Health	Atlanta District Office	DDMAC/Promotional Claims False & Misleading/Misbranded	N/A *
June 02, 2008	Dherbs.com	Los Angeles District Office	New Drug/Labeling/False Promotional Statements/Misbranded	N/A *
June 01, 2008	Synapse Biomedical Inc.	Center for Devices and Radiological Health	Clinical Investigator (Sponsor)	N/A *
May 30, 2008	Sandstone Medical Technologiess, LLC	New Orleans District Office	CGMP/QSR/Medical Devices/Adulterated/Misbranded	N/A *

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