Inspections, Compliance, Enforcement, and Criminal Investigations
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 July 10, 2009
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| 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 * |
| November 21, 2006 | Trionix Research Laboratory, Inc. | Cincinnati District Office | CGMP Requirements of the Quality System Regulations/Adulterated | N/A * |
| November 19, 2006 | Sanochemia Pharmazeutika AG | Center for Biologics Evaluation and Research | Quality System Regulation | N/A * |
| November 17, 2006 | Crabs, LLC | New Orleans District Office | Seafood HACCP/Adulterated | N/A * |
| November 16, 2006 | Pride of the South Catfish, Inc. | New Orleans District Office | Seafood HACCP/CGMP for Foods/Adulterated | N/A * |
| November 15, 2006 | Aqueous Biomedical, Inc. | Center for Devices and Radiological Health | Sponsor Obligations | N/A * |
| November 15, 2006 | Evanston Regional Hospital | Dallas District Office | Mammography Quality Standards Act | N/A * |
| November 14, 2006 | Sea Port Products Corporation | San Francisco District Office | Seafood HACCP/GMP for Foods/Adulterated | N/A * |
| November 14, 2006 | Vermeer Dairy | Seattle District Office | Edible Tissues/Adulterated | N/A * |
| November 14, 2006 | New England Lobster Company Inc. | San Francisco District Office | Seafood HACCP/GMP for Foods/Adulterated | N/A * |
| November 14, 2006 | Shin Hwa Wholesale Distributor, Inc. | San Francisco District Office | Seafood HACCP/GMP for Foods/Adulterated | N/A * |







