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 26, 2010
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
October 20, 2010 | Lippton, Howard M.D. | Center for Drug Evaluation and Research | Clinical Investigator | Not Issued * |
October 20, 2010 | Pacific Fishing Company Limited | Center for Food Safety and Applied Nutrition | CGMP for Foods/Seafood HACCP/Adulterated | Not Issued * |
October 20, 2010 | Vita-Herb Nutriceuticals, Inc. | Los Angeles District Office | CGMP For Manufacturing, Packing, Labeling, or Holding for Dietary Supplements/Adulterated | Not Issued * |
October 20, 2010 | Scott, David F., M.D. | Center for Drug Evaluation and Research | Clinical Investigator | Not Issued * |
October 20, 2010 | Axis Health Care LLC | New Orleans District Office | CGMP/QSR/Medical Devices/Adulterated/Misbranded | Not Issued * |
October 18, 2010 | Mead Johnson Nutrition Company | Detroit District Office | Infant Formula/Labeling | December 03, 2010 |
October 15, 2010 | Quality Egg LLC | Kansas City District Office | PHS Act Violation/Adulterated | Not Issued * |
October 15, 2010 | Lighthouse Marina Partnership | New Jersey District Office | Seafood HACCP | Not Issued * |
October 15, 2010 | Yunnan Hande Bio-Tech. Co. Ltd. | Center for Drug Evaluation and Research | CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated | October 25, 2011 |
October 15, 2010 | Living Naturally | Florida District Office | New Drug/Adulterated/Misbranded | Not Issued * |
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