Inspections, Compliance, Enforcement, and Criminal Investigations
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2012 Warning Letters
Posted on May 29, 2012
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| May 18, 2012 | Process Managers LLC | Cincinnati District Office | New Animal Drug/Adulterated | October 19, 2012 |
| May 18, 2012 | Arrowhead DE LLC, DBA Arrowhead Medical Device Technologies | New Orleans District Office | CGMP/QSR/Medical Devices/Adulterated | April 16, 2013 |
| May 17, 2012 | The Lebanon Corp., Inc. | Detroit District Office | CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation | Not Issued * |
| May 17, 2012 | Capitol Foods, Inc. | Baltimore District Office | Seafood HACCP/Adulterated/Misbranded | Not Issued * |
| May 17, 2012 | Neukom Groves, Inc. | Florida District Office | Juice HACCP | May 07, 2013 |
| May 17, 2012 | Vienna Beauty Products | Cincinnati District Office | Cosmetics/Adulterated/Misbranded | Not Issued * |
| May 15, 2012 | C.I. Farmacapsulas S.A. | Center for Drug Evaluation and Research | Failure to register and list | November 29, 2012 |
| May 15, 2012 | Smak Sp. z o.o. | Center for Food Safety and Applied Nutrition | Acidified Foods/Adulterated | November 02, 2012 |
| May 14, 2012 | Caribe Natural LLC | Florida District Office | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated | Not Issued * |
| May 14, 2012 | A&M De Sousa Dairy | San Francisco District Office | Illegal Drug Residue | Not Issued * |
| May 14, 2012 | Copan ltalia | Center for Devices and Radiological Health | Device/Adulterated | Not Issued * |
| May 11, 2012 | www.Low-Price-Cigarettes.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Not Issued * |
| May 11, 2012 | Amor Nino Foods Inc | San Francisco District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Not Issued * |
| May 11, 2012 | Classica Trading Center | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Not Issued * |
| May 11, 2012 | Lym-R-Flo Farm | New York District Office | Illegal Drug Residue | January 04, 2013 |
| May 10, 2012 | BTS S.p.A. | Center for Devices and Radiological Health | Device/Adulterated | Not Issued * |
| May 10, 2012 | Acorda Therapeutics Inc. | New York District Office | Adverse Drug Experience (ADE) | Not Issued * |
| May 10, 2012 | Siemens Healthcare Diagnostics, Inc | New England District Office | CGMP/QSR/Medical Devices/Adulterated | May 03, 2013 |
| May 09, 2012 | Terumo Medical Products Hangzhou Co., Ltd. | Center for Devices and Radiological Health | Adulterated Device | Not Issued * |
| May 08, 2012 | Mediagnost GmbH | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
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