2009 Warning Letters

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Warning Letters issued in 2009

 

* 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 July 28, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
July 15, 2009	Mgs Soapopular	Center for Drug Evaluation and Research	Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus	N/A *
July 14, 2009	Van Raay Dairy Farm	Cincinnati District Office	Illegal Drug Residue	N/A *
July 14, 2009	Perez Ident Peppers	Dallas District Office	Current Good Manufacturing Practice in Manufacturing Packing or Holding Human Food	N/A *
July 10, 2009	Universal Health Sciences	Center for Food Safety and Applied Nutrition	Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus	N/A *
July 10, 2009	Allera Health Products, Inc.	Center for Food Safety and Applied Nutrition	Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus	N/A *
July 09, 2009	www.balanceayurvedic.com	Los Angeles District Office	Promotional Claims False & Misleading/Misbranded	N/A *
July 08, 2009	Corporacion Los Hermanos, Inc. (DBA Panaderia America)	San Juan District Office	Food Product Manufacturing Facitity/Labeling	N/A *
July 07, 2009	Bazaar Of India	San Francisco District Office	New Drug/Labeling/Misbranded	N/A *
July 07, 2009	Hillcrest Bakery Inc.	Seattle District Office	CGMP Regulation For Food/Adulterated	N/A *
July 06, 2009	Shanghai Co Inc	Seattle District Office	CGMP Regulation For Food/Adulterated	N/A *
July 02, 2009	Gambro Dasco S.p.A. Bloodline Division	Center for Devices and Radiological Health	CGMP/QSR/Medical Devices/Adulterated	N/A *
July 02, 2009	Christus St. Patrick Hospital IRB	Center for Devices and Radiological Health	CGMP for Medical Devices/QS/Adulterated	N/A *
July 02, 2009	Gambro Renal Products S.A. de C.V.	Center for Devices and Radiological Health	CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated	N/A *
July 01, 2009	R & Z Ventures dba Kennesaw Fruit & Juice	Florida District Office	Juice HACCP	N/A *
July 01, 2009	Jones, Thomas M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
July 01, 2009	Northwest Tofu, Inc.	Seattle District Office	Current Good Manufacturing Practice Regulations for Human Foods/Adulterated	N/A *
July 01, 2009	Sparkle Spring Water Inc.	Atlanta District Office	CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Misbranded/Insanitary Conditions	N/A *
July 01, 2009	Rock Creek Dairy #3	Seattle District Office	Illegal Drug Residue	N/A *
June 30, 2009	J-Tel, Inc dba Buxton Foods	Minneapolis District Office	Labeling/False & Misleading Claims/Misbranded	N/A *
June 29, 2009	Sylvane Inc.	Center for Devices and Radiological Health	Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus	N/A *
June 29, 2009	Banyan Botanicals	Denver District Office	New Drug/Labeling/Misbranded	N/A *
June 29, 2009	Staten Island University Hospital IRB	Center for Devices and Radiological Health	Institutional Review Board (IRB)	N/A *
June 26, 2009	Gaven Medical	New England District Office	CGMP/QSR/Adulterated	N/A *
June 26, 2009	Advanced Neuromodulation Systems, Inc	Dallas District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
June 26, 2009	Gordon, Mark, M.D.	Center for Drug Evaluation and Research	Clinical Investigator	N/A *
June 26, 2009	FAVPEP LLC. dba Queenmar LLC.	Florida District Office	Adulterated Food	N/A *
June 25, 2009	IntelSource Group Inc dba Electro Medical Technologies LLC	Center for Devices and Radiological Health	Premarket Approval/Adulterated	N/A *
June 25, 2009	Laboratoire Atlas Inc.	Center for Drug Evaluation and Research	Pharmaceutical Manufacturing Facility/CGMP	N/A *
June 25, 2009	Apotex Inc.	Center for Drug Evaluation and Research	CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated	N/A *
June 25, 2009	Chesterfield Dairy	Cincinnati District Office	Illegal Drug Residue	N/A *
June 24, 2009	Accumed Inc.	New Jersey District Office	CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated	N/A *
June 23, 2009	Nutronix	Center for Food Safety and Applied Nutrition	Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus	N/A *
June 23, 2009	Island Supplements	Center for Food Safety and Applied Nutrition	Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus	N/A *
June 23, 2009	Apotheca Inc	Los Angeles District Office	CGMP Manufacture, Processing, Packing or Holding/Adulterated	N/A *
June 22, 2009	Circle T Dairy	Dallas District Office	Illegal Drug Residue	N/A *
June 18, 2009	Las Botanas	Los Angeles District Office	CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated	N/A *
June 18, 2009	Natren, Inc.	Center for Food Safety and Applied Nutrition	Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus	N/A *
June 17, 2009	Niitikaya USA Inc.	Los Angeles District Office	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions	N/A *
June 16, 2009	Zosa, Noli R., M.D.	Center for Drug Evaluation and Research	Clinical Investigator	N/A *
June 16, 2009	International Desserts and Delicacies	Los Angeles District Office	CGMP Regulation For Food/Adulterated	N/A *
June 16, 2009	Matrixx Initiatives, Inc. AKA Zicam LLC	Center for Drug Evaluation and Research	OTC Drug Labeling/New Drug/Misbranded	N/A *
June 15, 2009	Dennis Paper and Food Service	New England District Office	Seafood HACCP/CGMP for Foods/Adulterated	N/A *
June 15, 2009	Arkray Factory, Inc.	Center for Devices and Radiological Health	CGMP/QSR/Medical Devices/Adulterated	N/A *
June 15, 2009	Sunshine Peanut Company	Florida District Office	CGMP/Foods/Insanitary Conditions	N/A *
June 12, 2009	Circle of Health, Inc, www.ayurveda-herbs.com	Seattle District Office	New Drug/Labeling/Misbranded	N/A *
June 12, 2009	Linzer, Dov M.D.	Center for Drug Evaluation and Research	Clinical Investigator	N/A *
June 11, 2009	Meridian Lifeforce, Inc	Center for Food Safety and Applied Nutrition	Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus	N/A *
June 10, 2009	Arjo Med. AB	Center for Devices and Radiological Health	CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated	N/A *
June 10, 2009	Inditherm Medical	Center for Devices and Radiological Health	CGMP/QSR/Medical Devices/Adulterated	N/A *
June 09, 2009	Universal Blanchers LLC	Dallas District Office	CGMP/Adulterated	N/A *

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