Inspections, Compliance, Enforcement, and Criminal Investigations
2005 Warning Letters
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Warning Letters issued in 2005
* 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 |
|---|---|---|---|---|
| October 04, 2005 | HemoSense Corporation | San Francisco District Office | Medical Device Reporting/Misbranded | N/A * |
| October 04, 2005 | Blood Bank of the Redwoods | San Francisco District Office | Current Good Manufacturing Practice (cGMP) regulations for Blood and Blood Components/adulterated | N/A * |
| October 04, 2005 | Highland Laboratories, Inc. | Seattle District Office | Lacks Approved New Drug Application | N/A * |
| October 03, 2005 | Ross, Michelle A. MD | Center for Devices and Radiological Health | Clinical Investigator | N/A * |
| October 03, 2005 | Callahan Dairy | Seattle District Office | Illegal Drug Residue | N/A * |
| October 01, 2005 | Payson Fruit Growers, Inc. | Denver District Office | Labeling/New Drug/False & Misleading Claims/Misbranded | N/A * |
| September 30, 2005 | Lobob Laboratories Inc. | San Francisco District Office | CGMP Requirement of the Quality System Regulation for Medical Device | N/A * |
| September 30, 2005 | Syntee Scientific Corp. | Center for Devices and Radiological Health | CGMP Medical Device Reporting/Adulterated/Misbranded | N/A * |
| September 30, 2005 | Phillip & Vincent Banks Dairy Farm | New Orleans District Office | Illegal Drug Residue | N/A * |
| September 29, 2005 | Parent, J. Rex, M.D. | Center for Devices and Radiological Health | Clinical Investigator | N/A * |
| September 29, 2005 | Pleasant View Farms, Inc. | Philadelphia District Office | Illegal Drug Residue /Adulterated | N/A * |
| September 29, 2005 | Healthwest Mineral | Seattle District Office | Labeling/Promotional Claims False & Misleading/New Drug/Misbranded | N/A * |
| September 29, 2005 | Boston Seafood Wholesale LLC | Florida District Office | Seafood HACCP/Adulterated | N/A * |
| September 29, 2005 | Canada Food Outlet, Inc. | Chicago District Office | Seafood HACCP | N/A * |
| September 29, 2005 | Smith Incredibull Farms | Philadelphia District Office | Illegal Drug Residue /Adulterated | N/A * |
| September 28, 2005 | Sunshine Packing & Noodle Co., Inc | Florida District Office | Labeling/Misbranded | N/A * |
| September 28, 2005 | Nephron Pharmaceuticals Corp | Florida District Office | CGMP for Finished Pharmaceuticals/Postmarketing Adverse Drug Experience/Adulterated | N/A * |
| September 28, 2005 | Bayou City Fish Co, Inc. | Dallas District Office | Seafood HACCP/Adulterated | N/A * |
| September 28, 2005 | Silver Spring Farm | Buffalo District Office | Animal Drug/Adulterated | N/A * |
| September 27, 2005 | Hawk Vending Services, Incorporated | Seattle District Office | Seafood HACCP | N/A * |







