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 January 18, 2011
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| November 26, 2010 | Shi Feng Zhang Dba Ginseng88 | Center for Food Safety and Applied Nutrition | False & Misleading Claims/Misbranded | Not Issued * |
| November 24, 2010 | Eagle Health Supplies, Inc. | Los Angeles District Office | CGMP/QS/Adulterated | November 06, 2012 |
| November 24, 2010 | Sagami Rubber Industries Co., Ltd. | Center for Devices and Radiological Health | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated | Not Issued * |
| November 22, 2010 | WalkMed Infusion, LLC | Denver District Office | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
| November 19, 2010 | Fujino Enterprises, Inc. | San Francisco District Office | Seafood HACCP/CGMP for Foods/Adulterated | Not Issued * |
| November 18, 2010 | AES Optics | New Orleans District Office | CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation | Not Issued * |
| November 18, 2010 | VanderVeer Center | Center for Drug Evaluation and Research | Misbranded/Labeling/Unauthorized Health Claims | July 26, 2011 |
| November 17, 2010 | Phusion Projects Inc. | Center for Food Safety and Applied Nutrition | Illegal Food Additive/Adulteration | Not Issued * |
| November 17, 2010 | YeYa Products Corp | Florida District Office | CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated | Not Issued * |
| November 17, 2010 | New Century Brewing Co | Center for Food Safety and Applied Nutrition | Illegal Food Additive/Adulteration | Not Issued * |
| November 17, 2010 | United Brands Company Inc | Center for Food Safety and Applied Nutrition | Illegal Food Additive/Adulteration | Not Issued * |
| November 17, 2010 | Align Technology Inc | San Francisco District Office | Device/Misbranded | Not Issued * |
| November 17, 2010 | Charge Beverages Corporation | Center for Food Safety and Applied Nutrition | Illegal Food Additive/Adulteration | Not Issued * |
| November 17, 2010 | Bobby Chez, Inc. | New Jersey District Office | Seafood HACCP | February 24, 2012 |
| November 16, 2010 | Eastern Cranial Affiliates, LLC | Baltimore District Office | CGMP/QSR/Medical Device Reporting/Misbranded | June 08, 2011 |
| November 16, 2010 | Empresas Y-nuina, Inc. | San Juan District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Not Issued * |
| November 15, 2010 | Fischer Surgical Inc | Center for Devices and Radiological Health | Premarket Approval/Misbranded/Adulterated | December 19, 2011 |
| November 12, 2010 | Artesian Trout Farm | Minneapolis District Office | Seafood HACCP/CGMP for Foods/Adulterated/Misbranded | May 08, 2012 |
| November 10, 2010 | Tws Marketing Group Inc. | Center for Food Safety and Applied Nutrition | Federal Food, Drug and Cosmetic Act/Misbranded | Not Issued * |
| November 10, 2010 | Oxygen Therapy Program | Florida District Office | New Drug/False Misleading/Labeling/Misbranded | Not Issued * |
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