Inspections, Compliance, Enforcement, and Criminal Investigations
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2013 Warning Letters
Posted on February 19, 2013
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| February 11, 2013 | Arizona Hydroponic Farming, LLC | Los Angeles District Office | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated | Not Issued * |
| February 11, 2013 | Supplementality LLC | Center for Food Safety and Applied Nutrition | Unapproved Products Related to the 2012/2013 Flu Season | Not Issued * |
| February 08, 2013 | Beehive Botanicals, Inc. | Minneapolis District Office | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated | Not Issued * |
| February 08, 2013 | Tan Extreme Inc | Chicago District Office | Premarket Approval Application (PMA) | Not Issued * |
| February 07, 2013 | University of Berkley | Center for Biologics Evaluation and Research | Unapproved Products Related to the 2012/2013 Flu Season | Not Issued * |
| February 06, 2013 | CTI Foods, LLC | Dallas District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Not Issued * |
| February 06, 2013 | Genesis Herb Company LLC | Cincinnati District Office | CGMP/Dietary Supplements/Adulterated/Misbranded | Not Issued * |
| February 05, 2013 | Futrex Incorporated | Baltimore District Office | Premarket Approval/Adulterated | Not Issued * |
| February 05, 2013 | Medsys s.a. | Center for Devices and Radiological Health | Medical Device Reporting Regulation/Misbranded | Not Issued * |
| February 04, 2013 | buy-pharma.com | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded | Not Issued * |
| February 04, 2013 | Big Mountain Drugs | Center for Drug Evaluation and Research | Unapproved New Drud/Misbranded | Not Issued * |
| February 04, 2013 | DC Nutrition, Inc. | Denver District Office | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated | Not Issued * |
| February 04, 2013 | Millane Dairy | Philadelphia District Office | Illegal Drug Residue | Not Issued * |
| February 01, 2013 | Singing River Hospital System IRB | Center for Drug Evaluation and Research | Institutional Review Board (IRB) | Not Issued * |
| January 31, 2013 | W. H. Walker Sons Inc | New York District Office | Juice/HACCP/Misbranded | Not Issued * |
| January 31, 2013 | Liquid Health, Inc. | Los Angeles District Office | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated | Not Issued * |
| January 30, 2013 | H & H Seafood | Dallas District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Not Issued * |
| January 30, 2013 | Mkg Provisions Inc | Florida District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Not Issued * |
| January 30, 2013 | Gourmet Cuisine, Inc. | Dallas District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Not Issued * |
| January 29, 2013 | www.cigrattesonlinebuy.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Not Issued * |
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