Inspections, Compliance, Enforcement, and Criminal Investigations
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2010 Warning Letters
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Warning Letters issued in 2010
* 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 September 28, 2010
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| September 10, 2010 | Rico Brand | Denver District Office | Seafood HACCP/CGMP for Foods/Adulterated | August 05, 2011 |
| September 09, 2010 | Absolute Packaging, Inc. | Florida District Office | CGMP for Finished Pharmaceuticals/Adulterated/Misbranded | Not Issued * |
| September 09, 2010 | Enriching Gifts International | Center for Food Safety and Applied Nutrition | Promotional Claims False & Misleading/New Drugs | January 13, 2011 |
| September 09, 2010 | Neil McIsaac & Son, Inc. | San Francisco District Office | Animal Sale for Slaughter as Food/Adulterated | Not Issued * |
| September 09, 2010 | Bay Regional Medical Center IRB | Center for Drug Evaluation and Research | Institutional Review Board (IRB) | Not Issued * |
| September 08, 2010 | Raber View Holstein | Cincinnati District Office | Illegal Drug Residue | December 28, 2011 |
| September 08, 2010 | Johnson Creek Enterprises, LLC | Minneapolis District Office | Unapproved New Drug/Misbranded/CGMP for Finished Pharmaceuticals | Not Issued * |
| September 08, 2010 | CeraSys, Incorporated | Los Angeles District Office | Medical Device Reporting (MDR) Regulation Misbranded/Adulterated | Not Issued * |
| September 08, 2010 | E-Cig Technology Inc. | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded | Not Issued * |
| September 08, 2010 | Ruyan America, Inc. | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded | Not Issued * |
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