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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
10/05/2010 Tropical Bakery Wholesale [ARCHIVED] Florida District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated 04/13/2011
10/05/2010 Zander Scientific, Inc. DBA Zander IVF, Inc. [ARCHIVED] Florida District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
10/05/2010 Natural Wellness, LLC [ARCHIVED] Florida District Office Unapproved New Drugs/Misbranded 11/07/2011
10/04/2010 Gold Coast Trading Co. [ARCHIVED] New York District Office Seafood HACCP 07/02/2012
10/01/2010 Brant-Wald Surgicals Inc [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
10/01/2010 Biotech International [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
10/01/2010 Sepal Reproductive Devices, Inc. [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
09/30/2010 Mutual Trading Company Inc [ARCHIVED] Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
09/30/2010 O'Barr, Thomas Jr., M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator Not Issued *
09/30/2010 Choksi Laboratory [ARCHIVED] Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
09/30/2010 Impact Instrumentation, Inc. [ARCHIVED] New Jersey District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded 01/09/2013
09/30/2010 Qualiphar Nv [ARCHIVED] Center for Drug Evaluation and Research CGMP for Finished Pharmaceutical/Adulterated Not Issued *
09/30/2010 DW Trading Inc. [ARCHIVED] Detroit District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated Not Issued *
09/29/2010 Newberry Farms, LLC Detroit District Office Illegal Drug Residue 12/10/2010
09/29/2010 Kyowa Hakko Kogyo Co., Ltd. [ARCHIVED] Center for Drug Evaluation and Research CGMP for Deviations/Adulterated 01/19/2012
09/29/2010 Snow, Lamar L. M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator Not Issued *
09/28/2010 Telledant LLC [ARCHIVED] Center for Food Safety and Applied Nutrition Dietary Supplement/Labeling False and Misleading/Misbranded Not Issued *
09/28/2010 St. Jeans Cannery Ltd. [ARCHIVED] Center for Food Safety and Applied Nutrition Deviations From Low Acid Canned Food Regulation/Adulterated Not Issued *
09/27/2010 Nexgen Pharma Inc [ARCHIVED] Los Angeles District Office CGMP for Finished Pharmaceutical/Unapproved New Drugs/Adulterated 03/06/2013
09/27/2010 Steris Isomedix Services, Inc. [ARCHIVED] Dallas District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
09/27/2010 Johnson & Johnson Consumer Group of Companies, Inc. [ARCHIVED] New Jersey District Office New Drug/False Misleading Labeling 11/23/2010
09/27/2010 Walgreen Company [ARCHIVED] Chicago District Office New Drug/False Misleading Labeling 03/21/2011
09/27/2010 CVS Pharmacy, Inc. [ARCHIVED] New England District Office New Drug/False Misleading Labeling 12/21/2010
09/24/2010 Kranenburg Dairy [ARCHIVED] Dallas District Office Illegal Drug Residue Not Issued *
09/24/2010 Rohrer Dairy Farms Llc [ARCHIVED] Philadelphia District Office Illegal Drug Residue Not Issued *
09/23/2010 Mundt & Associates, Inc. [ARCHIVED] Center for Devices and Radiological Health Electronic Product Radiation Control 12/15/2010
09/22/2010 Defibtech, LLC [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated 02/02/2012
09/22/2010 Spineology, Inc. [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization 10/12/2010
09/22/2010 Quality Plus Products, Inc. [ARCHIVED] Seattle District Office Seafood HACCP/Adulterated Not Issued *
09/21/2010 Gilead Sciences Inc [ARCHIVED] Los Angeles District Office CGMP for Finished Pharmaceuticals/Adulterated 08/04/2011
09/21/2010 Nature's Health Company, LLC [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved New Drug/Lacks New Drug Application/Misbranded 02/10/2011
09/21/2010 Tri-County Food Service & Distribution Inc [ARCHIVED] Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
09/21/2010 Rohr Fish, Inc. [ARCHIVED] Cincinnati District Office Seafood HACCP/Insanitary Conditions/Adulterated Not Issued *
09/21/2010 Perma Pure LLC [ARCHIVED] New Jersey District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded 10/26/2011
09/20/2010 Picus, Dr. Joel [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator 01/25/2013
09/17/2010 Trout Brothers Dairy Philadelphia District Office Illegal Drug Residue Not Issued *
09/16/2010 Ascension Orthopedics, Inc [ARCHIVED] Dallas District Office Medical Device Reporting(MDR) Regulation Misbranded 09/16/2011
09/15/2010 Fresenius Medical Care Holdings, Inc. [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated 11/05/2015
09/14/2010 Actelion Pharmaceuticals U.S., Inc. [ARCHIVED] San Francisco District Office Postmarketing Adverse Drug Experience (PADE) 06/13/2012
09/13/2010 Nissin Food Co Inc. USA [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Misbranded Not Issued *
09/10/2010 Rico Brand [ARCHIVED] Denver District Office Seafood HACCP/CGMP for Foods/Adulterated 08/05/2011
09/09/2010 Absolute Packaging, Inc. [ARCHIVED] Florida District Office CGMP for Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
09/09/2010 Bay Regional Medical Center IRB [ARCHIVED] Center for Drug Evaluation and Research Institutional Review Board (IRB) Not Issued *
09/09/2010 Neil McIsaac & Son, Inc. San Francisco District Office Illegal Drug Residue Not Issued *
09/09/2010 Enriching Gifts International [ARCHIVED] Center for Food Safety and Applied Nutrition Promotional Claims False & Misleading/New Drugs 01/13/2011
09/08/2010 Johnson Creek Enterprises, LLC [ARCHIVED] Minneapolis District Office Unapproved New Drug/Misbranded/CGMP for Finished Pharmaceuticals Not Issued *
09/08/2010 E-Cig Technology Inc. [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
09/08/2010 Ruyan America, Inc. [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
09/08/2010 Penguin Juice Company, Inc. [ARCHIVED] Detroit District Office Juice HACCP Not Issued *
09/08/2010 Raber View Holstein [ARCHIVED] Cincinnati District Office Illegal Drug Residue 12/28/2011

 

Contact FDA

Office of Regulatory Science and Innovation

Carol D. Linden, PhD

Director

301-796-8527

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