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 27, 2010
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| January 13, 2010 | K & S Wholesale Meat, Inc. | Minneapolis District Office | Seafood HACCP | October 22, 2012 |
| January 13, 2010 | C & S Wholesale Grocers, Inc | New England District Office | Seafood HACCP/CGMP for Foods/Adulterated | March 24, 2010 |
| January 13, 2010 | Royer Animal Health, LLC | Baltimore District Office | Unapproved New Animal Drug/Adulterated/Misbranded/Lack Registration | Not Issued * |
| January 13, 2010 | Gold Star Seafood, Inc. | Chicago District Office | Seafood HACCP/CGMP for Foods/Adulterated | December 14, 2010 |
| January 13, 2010 | Crystal Cove Seafood / Pt. Panca Mitra Multiperdana | Center for Food Safety and Applied Nutrition | Seafood HACCP | Not Issued * |
| January 13, 2010 | Innovative Beverage Groups Holdings, Inc | Dallas District Office | Labeling/Adulterated | Not Issued * |
| January 11, 2010 | Holistic Healing Devices | Center for Devices and Radiological Health | Premarket Approval/Misbranded/Adulterated | Not Issued * |
| January 11, 2010 | Munroe Regional Medical Centre | Center for Devices and Radiological Health | Medical Devices/Adulterated/Misbranded | Not Issued * |
| January 08, 2010 | Centaur, Inc. | Kansas City District Office | CGMP/Finished Pharmaceuticals/Adulterated | May 09, 2011 |
| January 07, 2010 | Cerebral Health, Llc | Florida District Office | Labeling/False & Misleading Claims/New Drug | Not Issued * |
| January 06, 2010 | Girard Spring Water Co., Inc. | New England District Office | Processing and Bottling of Bottled Drinking Water/Adulterated | December 07, 2010 |
| January 06, 2010 | Providence Hospital Institutional Review Board | Center for Devices and Radiological Health | Clinical Investigator | Not Issued * |
| January 05, 2010 | Apothecary Products, Inc. | Detroit District Office | Premarket Approval/Misbranded/Adulterated | Not Issued * |
| January 05, 2010 | Mountain Health Line | Center for Food Safety and Applied Nutrition | Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus | Not Issued * |
| January 05, 2010 | Ascential Experience Online | Center for Food Safety and Applied Nutrition | Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus | Not Issued * |
| January 05, 2010 | MyCloveCigarettes.com | Center for Tobacco Products | Tobacco Products/Adulterated/Misbranded | Not Issued * |
| January 05, 2010 | Ewin Soft and Trade SRL | Center for Tobacco Products | Tobacco Products/Adulterated/Misbranded | Not Issued * |
| January 05, 2010 | CloveCigarettesMart.com | Center for Tobacco Products | Tobacco Products/Adulterated/Misbranded | Not Issued * |
| January 05, 2010 | CloveCigarettesShop.com | Center for Tobacco Products | Tobacco Products/Adulterated/Misbranded | Not Issued * |
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