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 14, 2010
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
October 12, 2010 | Artery Health Institute LLC | New York District Office | Unapproved New Drugs/Misbranded | Not Issued * |
October 12, 2010 | World Health Products, Inc. | Denver District Office | Unapproved New Drugs/Misbranded | Not Issued * |
October 12, 2010 | Maxam Nutraceutics | Seattle District Office | Unapproved New Drugs/Misbranded | Not Issued * |
October 12, 2010 | Cardio Renew Inc | Minneapolis District Office | Unapproved New Drugs/Misbranded | August 29, 2011 |
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 | Not Issued * |
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 |
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