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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

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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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
October 12, 2010 Cardio Renew Inc Minneapolis District Office Unapproved New Drugs/Misbranded August 29, 2011
October 12, 2010 World Health Products, Inc. Denver District Office Unapproved New Drugs/Misbranded Not Issued *
October 12, 2010 Advanced Testing Laboratory Inc Cincinnati District Office CGMP for Finished Pharmaceuticals/Adulterated September 26, 2011
October 12, 2010 Artery Health Institute LLC New York District Office Unapproved New Drugs/Misbranded Not Issued *
October 08, 2010 Kanec USA, Inc. Florida District Office CGMP for Finished Pharmaceutical/Unapproved New Drugs/Adulterated/Misbranded Not Issued *
October 08, 2010 Rx-promotion Center for Drug Evaluation and Research Internet Marketing of Unapproved and Misbranded Drugs Not Issued *
October 07, 2010 Biostructures, LLC Los Angeles District Office Premarket Approval/Adulterated/Misbranded December 11, 2012
October 06, 2010 Thanh Son Tofu Inc Los Angeles District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
October 06, 2010 Fresh Express Incorporated San Francisco District Office False & Misleading Claims/Misbranded Not Issued *
October 05, 2010 Tropical Bakery Wholesale 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. Florida District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
October 05, 2010 Natural Wellness, LLC Florida District Office Unapproved New Drugs/Misbranded November 07, 2011
October 05, 2010 Longway Farm New England District Office Animals for Sale for Slaughter as Food/Adulterated October 26, 2010
October 04, 2010 Gold Coast Trading Co. New York District Office Seafood HACCP July 02, 2012
October 01, 2010 Sepal Reproductive Devices, Inc. New England District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
October 01, 2010 Biotech International Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
October 01, 2010 Brant-Wald Surgicals Inc New Orleans District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
September 30, 2010 Impact Instrumentation, Inc. New Jersey District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded January 09, 2013
September 30, 2010 Mutual Trading Company Inc Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
September 30, 2010 DW Trading Inc. Detroit District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated Not Issued *



 

Contact FDA

FDA's Office of Critical Path and Regulatory Science Initiatives

Frank F. Weichold, MD, PhD

Acting Director

Critical Path and Regulatory Science Initiatives

301-796-8187

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