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 |
---|---|---|---|---|
July 15, 2010 | RT Naturals, LLC | Los Angeles District Office | Unapproved New Drug/Misbranded | Not Issued * |
July 14, 2010 | VertiFlex, Inc. | Los Angeles District Office | Premarket Approval/Adulterated | December 15, 2010 |
July 13, 2010 | Hill, Brian & Barbara | Chicago District Office | Animal Sale for Slaughter as Food/Adulterated | Not Issued * |
July 13, 2010 | Cincinnati Sub-Zero Products Inc | Cincinnati District Office | CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated | January 17, 2012 |
July 12, 2010 | Circulatory Technology Inc | New York District Office | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated | February 17, 2012 |
July 12, 2010 | Amstech Incorporated | Center for Devices and Radiological Health | Electronic Product Radiation Control | Not Issued * |
July 09, 2010 | Beckman, Robert L. | New York District Office | Animal Sale for Slaughter as Food/Adulterated | Not Issued * |
July 09, 2010 | Med Prep Consulting, Inc | New Jersey District Office | Failure to Register and List/Misbranded | Not Issued * |
July 08, 2010 | Florida Bottling, Inc. | Florida District Office | New Drug/Drug Labeling/Misbranded | March 31, 2011 |
July 06, 2010 | Triple G Dairy | Los Angeles District Office | Animal Sale for Slaughter as Food/Adulterated | August 05, 2010 |
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