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 March 09, 2010
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
March 01, 2010 | Paddock Laboratories, Inc. | Center for Drug Evaluation and Research | New Drugs | Not Issued * |
March 01, 2010 | Edwards Lifesciences, LLC | Center for Devices and Radiological Health | Device/Misbranded | Not Issued * |
February 26, 2010 | Guidewire Technologies, Inc. | New England District Office | CGMP/QSR/Medical Devices/Adulterated | September 28, 2010 |
February 25, 2010 | Cucina Fresca, Inc. | Seattle District Office | Seafood HACCP | Not Issued * |
February 25, 2010 | Olympus Temmo Biomaterials Corporation - Mishima Factory | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
February 24, 2010 | Centrix Pharmaceutical Inc | New Orleans District Office | New Drug/Adulterated | Not Issued * |
February 24, 2010 | Acquired Holding Inc | Cincinnati District Office | Seafood HACCP | Not Issued * |
February 24, 2010 | Mueller Water Conditioning, Inc | Dallas District Office | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
February 23, 2010 | Karl Storz | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
February 23, 2010 | Arnold's Service Company, Inc. | Center for Devices and Radiological Health | UnapprovedlUncleared/Unauthorized Products Related to the H1N1 Flu Virus | Not Issued * |
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