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2006 Warning Letters
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Warning Letters issued in 2006
* 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 February 02, 2009
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
December 28, 2006 | Thomas Crab Company | Florida District Office | Seafood HACCP/Adulterated | N/A * |
December 27, 2006 | Applied Water Engineering, Inc. | Denver District Office | CGMP/QSR/Medical Device Reporting/Adulterated | N/A * |
December 27, 2006 | Tienda, Inc | Baltimore District Office | Seafood HACCP/Adulterated | N/A * |
December 27, 2006 | Rickland Farms, LLC | Minneapolis District Office | Animals for sale for slaughter/Adulterated | N/A * |
December 26, 2006 | Abraxis Bioscience, Inc. | Chicago District Office | Deviations from CGMP for Finished Pharmaceuticals | N/A * |
December 26, 2006 | Lee Laboratories, Inc. | Dallas District Office | CGMP Requirements of the Quality System Regulations/Adulterated | N/A * |
December 21, 2006 | Colusa Regional Medical Center | San Francisco District Office | Mammography Quality Standards | N/A * |
December 21, 2006 | Palmer Farms | New England District Office | Animals for sale for slaughter/Adulterated | N/A * |
December 21, 2006 | Sam's Homemade Cheesecake Inc. | Los Angeles District Office | CGMP Regulation For Food/Adulterated | N/A * |
December 20, 2006 | TMJ Implants, Inc. | Center for Devices and Radiological Health | Lacks Premarket Approval Application/Adulterated/Misbranded | N/A * |
December 20, 2006 | Sharma, Baljit K., M.D. | Center for Devices and Radiological Health | Clinical Investigator | N/A * |
December 20, 2006 | Williams Farms Inc. | New England District Office | Animals for sale for slaughter/Adulterated | N/A * |
December 18, 2006 | Biora AB | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | N/A * |
December 18, 2006 | FUZE Beverages, LLC | New Jersey District Office | CGMP/Food Labeling/New Drug | N/A * |
December 15, 2006 | Kingmar Seafood Corporation | Florida District Office | Seafood HACCP/Adulterated | N/A * |
December 12, 2006 | GSCM Ventures Inc. | San Francisco District Office | Labeling/Promotional Claims False & Misleading/New Drug/Misbranded | N/A * |
December 12, 2006 | LCDG Enterprise | San Francisco District Office | Seafood HACCP/Adulterated | N/A * |
December 12, 2006 | Viasys Healthcare | Cincinnati District Office | CGMP/Requirements for Medical Devices/QSR/Adulterated | N/A * |
December 08, 2006 | Schumacher's | New York District Office | Illegal Drug Residue | N/A * |
December 08, 2006 | Quick-Fill Mobile Oxygen, Inc. | New Orleans District Office | CGMP for Finished Pharmaceuticals/Adulterated | N/A * |
December 08, 2006 | Nasiff Associates, Inc. | New York District Office | CGMP/Adulterated | N/A * |
December 08, 2006 | Ganeden Biotech Inc. | Cincinnati District Office | Misbranded/Labeling/Unauthorized Health Claims | N/A * |
December 08, 2006 | MRL Inc. | Chicago District Office | CGMP For Medical Device Report/Adulterated | N/A * |
December 08, 2006 | Ratcliff, David C, M.D. | Center for Devices and Radiological Health | Institutional Review Board (IRB) | N/A * |
December 08, 2006 | Biotecx Laboratories, Inc. | Dallas District Office | CGMP/QSR/Medical Device Reporting/Adulterated | N/A * |
December 06, 2006 | INCELL Corporation, LLC | Center for Biologics Evaluation and Research | GLP/Bioresearch Monitoring Program/Investigational drugs | N/A * |
December 04, 2006 | Ritch, Robert M.D. | Center for Devices and Radiological Health | Clinical Investigator | N/A * |
December 04, 2006 | New England Compounding Center | New England District Office | Pharmacy Compounding/New Drug/Misbranded | N/A * |
December 04, 2006 | University Pharmacy | Denver District Office | Pharmacy Compounding/New Drug/Misbranded | N/A * |
December 04, 2006 | Customs Scripts Pharmacy | Florida District Office | Pharmacy Compounding/New Drug/Misbranded | N/A * |
December 04, 2006 | Triangle Compounding Pharmacy | Atlanta District Office | Pharmacy Compounding/New Drug/Misbranded | N/A * |
December 04, 2006 | Hal's Compounding Pharmacy, Inc | Center for Drug Evaluation and Research | Pharmacy Compounding/New Drug/Misbranded | N/A * |
December 04, 2006 | Feenstra, John | Seattle District Office | Illegal Drug Residue | N/A * |
December 04, 2006 | Ritch, Robert MD | Center for Devices and Radiological Health | Clinical Investigator | N/A * |
December 04, 2006 | Lamb Farms, Inc. | New York District Office | Illegal Drug Residue | N/A * |
December 01, 2006 | Spoonamore Drug Co., Inc. | Cincinnati District Office | Pharmacy Compounding/New Drug/Adulterated/Misbranded | N/A * |
November 30, 2006 | C.R.D. Group, Inc. | Florida District Office | Seafood HACCP/Adulterated | N/A * |
November 29, 2006 | Skytron | Detroit District Office | Current Good Manufacturing Requirements for Medical Devices/Adulterated | N/A * |
November 29, 2006 | Steris Corporation | New Orleans District Office | Medical Device Reporting (MDR) Regulation Misbranded/Adulterated | N/A * |
November 29, 2006 | HemoSense, Inc. | San Francisco District Office | CGMP for Medical Devices/QS/Adulterated | N/A * |
November 28, 2006 | Honolulu Fish & Seafood Corporation | San Francisco District Office | CGMP for Foods/Seafood HACCP/Adulterated | N/A * |
November 27, 2006 | Nestle S.A. | Minneapolis District Office | Infant Formula/Labeling/Misbranded | N/A * |
November 27, 2006 | Health Dimensions, Inc. | Detroit District Office | Pharmacy Compounding/New Drug/Misbranded | N/A * |
November 27, 2006 | Bessinger Pickle Company, Inc. | Detroit District Office | CGMP Manufacturing, Packing, or Holding Human Food/Adulterated | N/A * |
November 27, 2006 | Craftmatic Organization, Inc. | Philadelphia District Office | CGMP Requirements for Medical Devices/Quality System Regulation | N/A * |
November 22, 2006 | Conti, Ralph M., M.D. | Center for Biologics Evaluation and Research | Clinical Investigator | N/A * |
November 22, 2006 | Meyer Farm | Minneapolis District Office | Illegal Drug Residue /Adulterated | N/A * |
November 21, 2006 | Nardi, Claudia | Center for Devices and Radiological Health | Lacks Premarket Approval Application | N/A * |
November 21, 2006 | Natren Inc. | Los Angeles District Office | Labeling/Promotional Claims False & Misleading/Misbranded/Adulterated | N/A * |
November 21, 2006 | Dupaco, Inc. | Los Angeles District Office | Current Good Manufacturing Requirements for Medical Devices/Adulterated | N/A * |
Contact FDA
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Food and Drug Administration
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