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 June 25, 2010
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| June 09, 2010 | Busman Dairy | Seattle District Office | Illegal Drug Residue | Not Issued * |
| June 08, 2010 | Homeopathy For Health | Center for Drug Evaluation and Research | Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus | Not Issued * |
| June 08, 2010 | Piezosurgery Inc. | Cincinnati District Office | CGMP for Medical Devices/QS/Adulterated | March 29, 2011 |
| June 07, 2010 | Mamma Lina's, Inc. | Los Angeles District Office | Seafood HACCP/Adulterated | October 06, 2011 |
| June 07, 2010 | Arizant Inc | Center for Devices and Radiological Health | CGMP/QSR/Medical Device Reporting/Misbranded | Not Issued * |
| June 07, 2010 | Dick-mar Farms | Philadelphia District Office | Illegal Drug Residue | Not Issued * |
| June 04, 2010 | Atlas Operations, Inc. | Florida District Office | CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated | Not Issued * |
| June 04, 2010 | Troyer Farms | Detroit District Office | Animal Sale for Slaughter as Food/Adulterated | April 01, 2011 |
| June 03, 2010 | Twin Oaks Community Foods, Inc | Baltimore District Office | Food Labeling/Misbranded | July 19, 2011 |
| June 03, 2010 | Baxter Healthcare Corporation | Chicago District Office | Medical Device Reporting (MDR) Regulation/Adulterated | Not Issued * |
| June 02, 2010 | Fludefence.org | Center for Food Safety and Applied Nutrition | Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus | Not Issued * |
| June 02, 2010 | Saurabh Overseas | Center for Food Safety and Applied Nutrition | Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus | Not Issued * |
| June 02, 2010 | Privacyprotect.org | Center for Food Safety and Applied Nutrition | Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus | Not Issued * |
| June 02, 2010 | Swinefludefence.org | Center for Food Safety and Applied Nutrition | Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus | Not Issued * |
| June 02, 2010 | Encompass Group, LLC | Atlanta District Office | Medical Device Reporting (MDR) Regulation Misbranded | Not Issued * |
| June 02, 2010 | Fiesta Gourmet and Deli | Detroit District Office | Seafood HACCP/Adulterated | Not Issued * |
| June 01, 2010 | Sivertson Fisheries Inc | Minneapolis District Office | Seafood HACCP | Not Issued * |
| June 01, 2010 | Tejas Industries Inc. | Dallas District Office | Pet Treats for Sale as Food/Adulterated | Not Issued * |
| May 28, 2010 | Yancey, Samuel DVM | New York District Office | Illegal Drug Residue | Not Issued * |
| May 28, 2010 | American Sea Food Company, Inc. | Los Angeles District Office | Seafood HACCP/Adulterated | Not Issued * |
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