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 08, 2009
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| November 13, 2006 | Gerald Thompson Farm | Buffalo District Office | Illegal Drug Residue | N/A * |
| November 13, 2006 | Gyrus ENT, LLC | New Orleans District Office | CGMP Requirements of the Quality System Regulations/Adulterated | N/A * |
| November 13, 2006 | Becton Dickinson and Co | San Juan District Office | CGMP/QSR/Medical Devices/Adulterated | N/A * |
| November 09, 2006 | Nelson, Douglas Jr. | New England District Office | Illegal Drug Residue | N/A * |
| November 09, 2006 | Lakeview Farms, Inc. | Cincinnati District Office | Seafood HACCP/Adulterated | N/A * |
| November 09, 2006 | Delta Regional Medical Center | New Orleans District Office | Mammography Quality Standards Act | N/A * |
| November 08, 2006 | UCA, LLC | New Orleans District Office | CGMP/QSR/Medical Devices/Adulterated | N/A * |
| November 08, 2006 | Bartholomew, Bradley J., M.D. | Center for Devices and Radiological Health | Clinical Investigator | N/A * |
| November 07, 2006 | Mercy Mount Clemens Corporation | Center for Devices and Radiological Health | Institutional Review Board (IRB) | N/A * |
| November 07, 2006 | Schworer, Philip B. | Center for Drug Evaluation and Research | Clinical Investigator | N/A * |
| November 06, 2006 | Pierpont Seafood | Los Angeles District Office | Seafood HACCP/Adulterated | N/A * |
| November 06, 2006 | New England Smoked Seafood | New England District Office | CGMP for Foods/HACCP | N/A * |
| November 03, 2006 | Lawrence, E Clinton MD | Center for Drug Evaluation and Research | Clinical Investigator | N/A * |
| November 03, 2006 | Benchmark Medical, Inc. | Denver District Office | Labeling/OTC Human Use/New Drug/Misbranded | N/A * |
| November 02, 2006 | Country Maid, Inc. | Minneapolis District Office | Food Labeling/False & Misleading/Claims Misbranded | N/A * |
| November 02, 2006 | Direct Dispensing, Inc. | Florida District Office | Labeling/OTC Human Use/New Drug/Misbranded | N/A * |
| November 02, 2006 | Perkins Electronics Company | Dallas District Office | CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated | N/A * |
| November 01, 2006 | M & S Acquisition | Cincinnati District Office | CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated | N/A * |
| November 01, 2006 | Williams Seafood of Arapahoe Inc. | Atlanta District Office | CGMP for Foods/Seafood HACCP/Adulterated | N/A * |
| October 31, 2006 | Pharmacy Creations | New Jersey District Office | Pharmacy Compounding/New Drug/Misbranded | N/A * |







