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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

Posted on October 05, 2010

Letter Issue Date Company Name Issuing Office Subject Close Out Date
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 05, 2010 Zander Scientific, Inc. DBA Zander IVF, Inc. Florida District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
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 Brant-Wald Surgicals Inc New Orleans 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 *
September 30, 2010 Mutual Trading Company Inc Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
September 30, 2010 Choksi Laboratory Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
September 30, 2010 DW Trading Inc. Detroit District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated Not Issued *


 

Contact FDA

301-796-8490
FDA's Office of Critical Path Programs
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