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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2010 Warning Letters

Recently Posted | 2011 | 2010 | 2009 | 2008 | 2007 | 2006 | 2005

Warning Letters issued in 2010

 

* 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

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
06/02/2010 Swinefludefence.org [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
06/02/2010 Fludefence.org [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
06/02/2010 Saurabh Overseas [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
06/02/2010 Fiesta Gourmet and Deli [ARCHIVED] Detroit District Office Seafood HACCP/Adulterated Not Issued *
06/02/2010 Encompass Group, LLC [ARCHIVED] Atlanta District Office Medical Device Reporting (MDR) Regulation Misbranded Not Issued *
06/02/2010 Privacyprotect.org [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
06/01/2010 Tejas Industries Inc. [ARCHIVED] Dallas District Office Pet Treats for Sale as Food/Adulterated Not Issued *
06/01/2010 Sivertson Fisheries Inc [ARCHIVED] Minneapolis District Office Seafood HACCP Not Issued *
05/28/2010 American Sea Food Company, Inc. [ARCHIVED] Los Angeles District Office Seafood HACCP/Adulterated Not Issued *
05/28/2010 Yancey, Samuel DVM [ARCHIVED] New York District Office Illegal Drug Residue Not Issued *
05/27/2010 Italco Food Products, Inc. [ARCHIVED] Denver District Office Seafood HACCP/Adulterated 08/05/2011
05/27/2010 Industrias Alimentarias De Navarra, S.A.U. [ARCHIVED] Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated 09/16/2010
05/27/2010 Ribbon SRL [ARCHIVED] Center for Drug Evaluation and Research CGMP Regulation for Finished Pharmaceuticals/Adulterated 04/18/2011
05/26/2010 Pfizer, Inc. [ARCHIVED] New York District Office Postmarketing Adverse Drug Experience Reporting Requirements Not Issued *
05/25/2010 Flexcin International, Inc. [ARCHIVED] Florida District Office New Drug/Labeling/False & Misleading Claims Not Issued *
05/25/2010 Pharmline, Inc. [ARCHIVED] New York District Office Federal Food, Drug, and Cosmetic Act Violations/Radiation/Adulterated/Misbranded Not Issued *
05/25/2010 Tom Schantz Farm (d/b/a Riverview Dale Farm) [ARCHIVED] New York District Office Illegal Drug Residue Not Issued *
05/25/2010 Toby's Nose Filters, Inc. [ARCHIVED] Florida District Office Premarket Approval/Adulterated Not Issued *
05/24/2010 Syntron Bioresearch Inc. [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Device Reporting/Adulterated Not Issued *
05/21/2010 David Montanez Calf Farm [ARCHIVED] Dallas District Office Illegal Drug Residue Not Issued *
05/21/2010 Dexcom Inc [ARCHIVED] Los Angeles District Office Medical Device Reporting/Misbranded 07/15/2011
05/21/2010 Mickey's Snacks & Concession Supply Co. [ARCHIVED] Florida District Office Food Labeling/Misbranded 10/06/2010
05/21/2010 Feel Good Natural Health [ARCHIVED] Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
05/21/2010 Amigo Mobility International, Inc [ARCHIVED] Detroit District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
05/21/2010 Zone Of Natural Remedies [ARCHIVED] Center for Drug Evaluation and Research Unapproved/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
05/21/2010 K. C. Pharmaceuticals Inc. [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Finished Pharmaceuticals/Adulterated Not Issued *
05/21/2010 AVEVA Drug Delivery Systems, Inc. [ARCHIVED] Florida District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
05/20/2010 Hyperbaric for Life LLC [ARCHIVED] Los Angeles District Office Medical Device Reporting Regulation/Misbranded 07/15/2011
05/20/2010 River's Edge Pharmaceuticals, LLC [ARCHIVED] Atlanta District Office CGMP for Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
05/17/2010 A Simoes Family Dairy [ARCHIVED] Los Angeles District Office Illegal Drug Residue Not Issued *
05/17/2010 Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc. [ARCHIVED] Los Angeles District Office CGMP for Medical Devices/Adulterated Not Issued *
05/13/2010 Jilin Shulan Synthetic Pharmaceutical Co. Ltd. [ARCHIVED] Center for Drug Evaluation and Research CGMP for Deviations/Adulterated 05/31/2012
05/12/2010 Cogent Solutions Group LLC [ARCHIVED] Cincinnati District Office New Drug/Labeling/Misbranded 03/30/2011
05/12/2010 CMC Commodity Transport Inc. [ARCHIVED] Atlanta District Office Animal Feed/Adulterated with shredded tire chips Not Issued *
05/12/2010 Terry Yon & Associates, Inc./dba Tya Pharmaceuticals [ARCHIVED] Florida District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
05/12/2010 Laboratorios L.O., Oftalmi, C.A. [ARCHIVED] Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
05/12/2010 Miller, David L. [ARCHIVED] New York District Office Illegal Drug Residue Not Issued *
05/11/2010 Artegraft, Inc. [ARCHIVED] New Jersey District Office CGMP/QSR/Medical Devices/Adulterated 03/23/2011
05/11/2010 Molteno Ophthalmic Ltd [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated/Misbranded 08/22/2011
05/11/2010 Healthy World Distributing [ARCHIVED] Seattle District Office Promotional Claims/Misbranded Not Issued *
05/10/2010 Dolce, L.L.C. [ARCHIVED] Cincinnati District Office Seafood HACCP/Insanitary Conditions/Adulterated Not Issued *
05/10/2010 Service Smoked Fish Corp [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
05/10/2010 Willamette Shelling Inc [ARCHIVED] Seattle District Office CGMP Regulation For Food/Adulterated Not Issued *
05/10/2010 Len-acres [ARCHIVED] Seattle District Office Illegal Drug Residue Not Issued *
05/10/2010 Aurora Ridge Dairy, LLC [ARCHIVED] New York District Office Illegal Drug Residue Not Issued *
05/10/2010 Braintree Laboratories Inc [ARCHIVED] New England District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated 04/27/2011
05/10/2010 Midstate Veterinary Services, PLLC [ARCHIVED] New York District Office Illegal Drug Residue Not Issued *
05/07/2010 Medtronic Navigation, Inc [ARCHIVED] Denver District Office Medical Device/Lacks Premarket Approval/Adulterated/Misbranded Not Issued *
05/06/2010 C.V. Foods Corporation, DBA Yo Lily Cheesecake Co. [ARCHIVED] Los Angeles District Office CGMP Requirement for Food Manufacturing/Adulterated Not Issued *
05/03/2010 Trilliant Surgical, LTD [ARCHIVED] Dallas District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded 08/17/2012

 

Contact FDA

Office of Regulatory Science and Innovation

Carol D. Linden, PhD

Director

301-796-8527

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