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Inspections, Compliance, Enforcement, and Criminal Investigations
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2009 Warning Letters
Warning Letters for 2009
| Letter Issue Date | Company Name | Issuing Office | Subject |
|---|---|---|---|
| August 18, 2009 | MEKT LLC | New Jersey District Office | OTC Drug Products/Lacks New Drug Approval/Misbranded |
| August 18, 2009 | Meditrend, Inc | Denver District Office | OTC Drug Products/Lacks New Drug Approval/Misbranded |
| August 18, 2009 | Geromatrix Nutraceutical Corporation | Florida District Office | OTC Drug Products/Lacks New Drug Approval/Misbranded |
| August 18, 2009 | Progressive Emu Inc. | New Orleans District Office | OTC Drug Products/Lacks New Drug Approval/Misbranded |
| August 18, 2009 | Wonder Laboratories | New Orleans District Office | OTC Drug Products/Lacks New Drug Approval/Misbranded |
| August 18, 2009 | BioCentric Laboratories Inc. | Denver District Office | OTC Drug Products/Lacks New Drug Approval/Misbranded |
| August 18, 2009 | Core Products Int'L Inc | Minneapolis District Office | OTC Drug Products/Lacks New Drug Approval/Misbranded |
| August 17, 2009 | Allergan Inc. | Division of Drug Marketing, Advertising, and Communications | Labeling/Promotional Claims False & Misleading/Misbranded |
| August 13, 2009 | Ninth St. Management Inc. (Trades as Superior Pasta Co Inc.) | Philadelphia District Office | CGMP for Foods/Seafood HACCP/Adulterated |
| August 12, 2009 | Hospira Inc | San Francisco District Office | CGMP/QSR/Medical Devices/Adulterated |
| August 11, 2009 | Living Streams Mission, Inc | Center for Food Safety and Applied Nutrition | Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus |
| August 11, 2009 | Ridge Medical Products LLC | Dallas District Office | OTC Drug Products/Lacks New Drug Approval/Misbranded |
| August 10, 2009 | Johnson & Johnson Pharmaceutical Research & Development, LLC | Center for Drug Evaluation and Research | Sponsor |
| August 05, 2009 | Mexican Village Wholesale Foods, Inc | Minneapolis District Office | Acidified Foods/Emergency Permit Control/Adulterated/Misbranded |
| July 31, 2009 | G & H Dairy #1, LLC | Seattle District Office | Animals for Sale for Slaughter as Food/Adulterated |
| July 27, 2009 | Bodee LLC | Los Angeles District Office | Dietary Supplement/Labeling False and Misleading/Misbranded |
| July 27, 2009 | Americell-labs.com VMG Global Inc | San Francisco District Office | Dietary Supplements/Adulterated/Misbranded |
| July 27, 2009 | Harris, Barbara A | Center for Drug Evaluation and Research | Bioresearch Monitoring Program/IRB |
| July 24, 2009 | ABL - Antibiotics Do Brasil | Center for Drug Evaluation and Research | CGMP/Adulterated |
| July 24, 2009 | Hinsdale Farms, Ltd. | Detroit District Office | CGMP/Adulterated |
| July 23, 2009 | Chris' Seafood | New Orleans District Office | CGMP for Foods/Seafood HACCP/Adulterated |
| July 23, 2009 | Poly Packaging Systems, Inc. | New Orleans District Office | CGMP/QSR/Medical Devices/Adulterated/Misbranded |
| July 22, 2009 | Herbal Remedies | Center for Food Safety and Applied Nutrition | Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus |
| July 22, 2009 | Ohio Medical Corporation | Chicago District Office | CGMP/QSR/Medical Device/Adulterated |
| July 22, 2009 | Q-Based Solutions | Center for Drug Evaluation and Research | Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus |
| July 20, 2009 | Phillips, Robert A., M.D. | Center for Devices and Radiological Health | Investigational Device Exemptions |
| July 17, 2009 | La Madeleine Gourmet Foods, Inc. | Dallas District Office | Seafood HACCP/Adulterated |
| July 16, 2009 | Thurston, Jeff | Center for Food Safety and Applied Nutrition | Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus |
| July 15, 2009 | Mgs Soapopular | Center for Drug Evaluation and Research | Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus |
| July 14, 2009 | Perez Ident Peppers | Dallas District Office | Current Good Manufacturing Practice in Manufacturing Packing or Holding Human Food |
| July 14, 2009 | Abbott Laboratories | Division of Drug Marketing, Advertising, and Communications | DDMAC/Promotional Claims False & Misleading/Misbranded |
| July 13, 2009 | Alaven Pharmaceutical LLC | Center for Drug Evaluation and Research | Federal Food, Drug, and Cosmetic Act Violations/Misleading |
| July 10, 2009 | Allera Health Products, Inc. | Center for Food Safety and Applied Nutrition | Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus |
| July 10, 2009 | Universal Health Sciences | Center for Food Safety and Applied Nutrition | Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus |
| July 09, 2009 | www.balanceayurvedic.com | Los Angeles District Office | Promotional Claims False & Misleading/Misbranded |
| July 08, 2009 | Corporacion Los Hermanos, Inc. (DBA Panaderia America) | San Juan District Office | Food Product Manufacturing Facitity/Labeling |
| July 07, 2009 | Bazaar Of India | San Francisco District Office | New Drug/Labeling/Misbranded |
| July 07, 2009 | Hillcrest Bakery Inc. | Seattle District Office | CGMP Regulation For Food/Adulterated |
| July 06, 2009 | Shanghai Co Inc | Seattle District Office | CGMP Regulation For Food/Adulterated |
| July 02, 2009 | Gambro Renal Products S.A. de C.V. | Center for Devices and Radiological Health | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated |
| July 02, 2009 | Gambro Dasco S.p.A. Bloodline Division | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
| July 02, 2009 | Christus St. Patrick Hospital IRB | Center for Devices and Radiological Health | CGMP for Medical Devices/QS/Adulterated |
| July 01, 2009 | Northwest Tofu, Inc. | Seattle District Office | Current Good Manufacturing Practice Regulations for Human Foods/Adulterated |
| July 01, 2009 | Rock Creek Dairy #3 | Seattle District Office | Animals for Sale for Slaughter as Food/Adulterated |
| July 01, 2009 | Jones, Thomas M.D. | Center for Devices and Radiological Health | Clinical Investigator |
| June 30, 2009 | J-Tel, Inc dba Buxton Foods | Minneapolis District Office | Labeling/False & Misleading Claims/Misbranded |
| June 29, 2009 | Staten Island University Hospital IRB | Center for Devices and Radiological Health | IRB (Institutional Review Board) |
| June 26, 2009 | Gordon, Mark, M.D. | Center for Drug Evaluation and Research | Clinical Investigator |
| June 26, 2009 | FAVPEP LLC. dba Queenmar LLC. | Florida District Office | Adulterated Food |
| June 26, 2009 | Advanced Neuromodulation Systems, Inc | Dallas District Office | CGMP/QSR/Medical Devices/Adulterated |
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