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 September 09, 2010
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
September 08, 2010 | E-CigaretteDirect, LLC | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded | Not Issued * |
September 08, 2010 | Gamucci | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded | Not Issued * |
September 08, 2010 | Penguin Juice Company, Inc. | Detroit District Office | Juice HACCP | Not Issued * |
September 07, 2010 | Quinault Indian Nation | Seattle District Office | CGMP for Foods/Adulterated | Not Issued * |
September 07, 2010 | Hard-E Foods Inc | Kansas City District Office | Acidified Foods/Emergency Permit Control/Adulterated/Misbranded | Not Issued * |
September 03, 2010 | Intec Industries Inc | New Orleans District Office | Device/Adulterated | Not Issued * |
September 03, 2010 | Sutures India Pvy. Ltd. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated/Misbranded | Not Issued * |
September 02, 2010 | Quong Hop & Co | San Francisco District Office | CGMP for Foods/HACCP/Adulterated | Not Issued * |
September 01, 2010 | Fairfield Gourmet Food Corp | Center for Food Safety and Applied Nutrition | Nutrition Labeling of Food/Misbranded | Not Issued * |
September 01, 2010 | Frontier Medical Products | Minneapolis District Office | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated | Not Issued * |
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