Inspections, Compliance, Enforcement, and Criminal Investigations
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2012 Warning Letters
Posted on May 22, 2012
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| May 08, 2012 | www.online-dutyfree.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Not Issued * |
| May 08, 2012 | Reaction Nutrition, L.L.C. | Philadelphia District Office | CGMP for Dietary Supplements/Adulterated/Misbranded | November 08, 2012 |
| May 08, 2012 | Mediagnost GmbH | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
| May 07, 2012 | Belmont Instrument Corporation | Center for Devices and Radiological Health | Medical Device/Adulterated/Misbranded | Not Issued * |
| May 07, 2012 | CareFusion Corp dba Productos Urologos De Mexico S.A. De C.V. | Center for Devices and Radiological Health | Device/Adulterated | July 19, 2012 |
| May 07, 2012 | Millar Instruments, Inc. | Dallas District Office | Device/Adulterated | Not Issued * |
| May 07, 2012 | Quadex Pharmaceuticals, LLC | Denver District Office | OTC Drug Labeling/New Drug/Misbranded | Not Issued * |
| May 07, 2012 | ThermaSolutions Incorporated | Center for Devices and Radiological Health | Medical Device/Adulterated/Misbranded | Not Issued * |
| May 07, 2012 | info@discount-cigarettes-online.biz | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Not Issued * |
| May 04, 2012 | B.M.P. Pharma Trading AG | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | Not Issued * |
| May 03, 2012 | Stingray Surgical Products, LLC | Florida District Office | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
| May 03, 2012 | Inova Health Care Services, Inova Blood Donor Services | Baltimore District Office | CGMP Regulation for Blood and Blood Products/Adulterated | November 29, 2012 |
| May 02, 2012 | El Toro Farm Fresh Cheese Co. | Atlanta District Office | CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions | Not Issued * |
| May 02, 2012 | Amplivox Ltd | Center for Devices and Radiological Health | CGMP for Medical Devices/QSR/Adulterated | Not Issued * |
| May 02, 2012 | Andersen Sterilizers Inc | Atlanta District Office | Premarket Approval/Misbranded | Not Issued * |
| May 01, 2012 | Sea World, Inc. | San Juan District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Not Issued * |
| May 01, 2012 | O'Kroft Family Foods d.b.a. Willie B's | Dallas District Office | Acidified Foods/Adulterated | Not Issued * |
| May 01, 2012 | Freshwater Fish Products, Inc. | Dallas District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Not Issued * |
| May 01, 2012 | JC's Fish & BBQ Inc. | Dallas District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Not Issued * |
| May 01, 2012 | Sulphur Springs Dairy Auction, Inc. | Dallas District Office | Illegal Drug Residue | Not Issued * |
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