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 April 20, 2010
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
April 05, 2010 | 7Seas LLC | Florida District Office | Dietary Supplement Regulations/Misbranded | Not Issued * |
April 05, 2010 | All About You Medspa, LLC | Center for Drug Evaluation and Research | Lipodissolve/False & Misleading Claims/Misbranded | Not Issued * |
April 02, 2010 | Wright Place, LLC | New England District Office | Illegal Drug Residue | Not Issued * |
April 01, 2010 | Yurkanin, John B | Philadelphia District Office | Illegal Drug Residue | Not Issued * |
April 01, 2010 | Deitz, Robert, M.D. | Center for Drug Evaluation and Research | Clinical Investigator | Not Issued * |
March 31, 2010 | Cut Fruit Express, Inc. | Minneapolis District Office | CGMP for Foods/HACCP/Adulterated | February 08, 2011 |
March 30, 2010 | Coats International Holdings, Inc | Dallas District Office | CGMP Manufacture, Processing, Packing or Holding/Adulterated | Not Issued * |
March 30, 2010 | Wisconsin Brother's Bakery, Inc | Minneapolis District Office | Labeling/False & Misleading Claims/Misbranded | Not Issued * |
March 29, 2010 | IVF Phoenix | Los Angeles District Office | Human Cells, Tissues & Cellular Products | July 18, 2011 |
March 29, 2010 | Apotex Inc. | Center for Drug Evaluation and Research | CGMP for Finished Pharmaceuticals/Adulterated | July 01, 2011 |
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