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