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

 

Contact FDA

Office of Regulatory Science and Innovation

Carol D. Linden, PhD

Director

301-796-8527

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