Inspections, Compliance, Enforcement, and Criminal Investigations
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2011 Warning Letters
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Warning Letters issued in 2011
* 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 November 08, 2011
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| October 31, 2011 | IndoCigs | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Not Issued * |
| October 31, 2011 | AD and AD International, Ltd. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Not Issued * |
| October 28, 2011 | Alabama Sunshine, Inc. | New Orleans District Office | CGMP/Acidified Foods/Adulterated | Not Issued * |
| October 28, 2011 | Wrapers Kitchen | Denver District Office | Seafood HACCP/CGMP for Foods/Adulterated | Not Issued * |
| October 28, 2011 | Hayai Zushi | Denver District Office | Seafood HACCP/CGMP for Foods/Adulterated | Not Issued * |
| October 27, 2011 | Seven Seas Seafoods Inc. | Los Angeles District Office | Seafood HACCP/Adulterated | Not Issued * |
| October 27, 2011 | Joe L. Pimentel Dairy | San Francisco District Office | Illegal Drug Residue/Adulterated | Not Issued * |
| October 26, 2011 | Laser Eye Care of California, LLC | Center for Devices and Radiological Health | Medical Device Reporting/Misbranded | Not Issued * |
| October 26, 2011 | B & F Fish Market Llc | New Orleans District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Not Issued * |
| October 26, 2011 | Silveira Ranches | San Francisco District Office | New Animal Drug/Adulterated | Not Issued * |
| October 26, 2011 | International Isotopes Inc. | Seattle District Office | CGMP for Finished Pharmaceuticals/Adulterated | Not Issued * |
| October 26, 2011 | SterilMed, Inc. | Center for Devices and Radiological Health | Adulterated Device/Misbranding | May 22, 2012 |
| October 26, 2011 | Great American Marketing Company | Dallas District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Not Issued * |
| October 25, 2011 | Onorato & Company, Inc. | San Francisco District Office | CGMP for Foods/Seafood HACCP/Adulterated | Not Issued * |
| October 25, 2011 | Southwest Traders, Inc. | Dallas District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Not Issued * |
| October 25, 2011 | Van Deurzen Dairy, LLC | Cincinnati District Office | Illegal Drug Residue/Adulterated | Not Issued * |
| October 25, 2011 | Lester Troyer Farm | Cincinnati District Office | Illegal Drug Residue | Not Issued * |
| October 24, 2011 | Pastry Food Products, Inc. | San Juan District Office | CGMP Manufacture, Processing, Packing or Holding Food/Adulterated/Misbranded | Not Issued * |
| October 24, 2011 | Sea Fare Foods, Inc. | Detroit District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | January 10, 2013 |
| October 24, 2011 | Procesadora El Cangrejito Del Mar C.A. (Procamar, C.A.) | Center for Food Safety and Applied Nutrition | Seafood HACCP/CGMP for Foods/Adulterated | Not Issued * |
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