Inspections, Compliance, Enforcement, and Criminal Investigations
2003 Warning Letters
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Warning Letters issued in 2003
* 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 June 30, 2009
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| September 18, 2003 | South China Seafood Co. | Los Angeles District Office | Seafood HACCP/Adulterated | N/A * |
| September 18, 2003 | Alaska Sausage & Seafood Company, Inc. | Seattle District Office | Seafood HACCP/Good Manufacturing Practice Regulations | N/A * |
| September 18, 2003 | Drawdy's Crab Company, Inc. | New Orleans District Office | Seafood HACCP/Adulterated | N/A * |
| September 18, 2003 | Giovanni's Aloha Foods, LLC | San Francisco District Office | Food Labeling/Misbranded/Acidified Foods | N/A * |
| September 18, 2003 | K & T Oriental Imports | Dallas District Office | Seafood HACCP/Adulterated | N/A * |
| September 17, 2003 | HDC Corporation | San Francisco District Office | Quality System Regulation/Medical Device Reporting/Adulterated/Misbranded | N/A * |
| September 17, 2003 | Oak Lawn Institutional Review Board | Center for Devices and Radiological Health | Institutional Review Board | N/A * |
| September 17, 2003 | Esteves Dairy | San Francisco District Office | Illegal Drug Residue/Animal Tissue/Adulterated | N/A * |
| September 17, 2003 | Guam's Bakery, Inc. | San Francisco District Office | GMP in Manufacturing, Packing, or Holding Human Food/Interstate Conveyance Regulations/Adulterated | N/A * |
| September 17, 2003 | Formar Import & Export Inc. | Dallas District Office | Import Food Not Held Intact/Substitution of Product | N/A * |
| September 17, 2003 | Oraceutical, LLC | New England District Office | New Animal Drug/Adulterated | N/A * |
| September 17, 2003 | Bayside Shellfish | New England District Office | Seafood HACCP/Adulterated | N/A * |
| September 16, 2003 | CanaRx Services, Inc. | Center for Drug Evaluation and Research | Illegal Canadian Drug Importation | N/A * |
| September 16, 2003 | C.R. Bard, Inc. | Atlanta District Office | Device/Lacks Premarket Approval Application/Adulterated/Misbranded | N/A * |
| September 16, 2003 | BWild Inc. | Center for Devices and Radiological Health | Tinted Contact Lenses/Adulterated/Misbranded | N/A * |
| September 16, 2003 | Reichel Foods, LLC | Minneapolis District Office | Food Labeling/New Drugs/Misbranded | N/A * |
| September 15, 2003 | Beach Smoke House | Baltimore District Office | Seafood HACCP/Adulterated | N/A * |
| September 15, 2003 | Guam International Airport Authority | San Francisco District Office | Interstate Conveyance Sanitation Regulations | N/A * |
| September 15, 2003 | AMR Corp./American Airlines, Inc. | San Francisco District Office | Interstate Conveyance Sanitation Regulations | N/A * |
| September 15, 2003 | SkyWest Airlines, Inc. | San Francisco District Office | Interstate Conveyance Sanitation Regulations | N/A * |
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