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 December 07, 2010
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
September 27, 2010 | Steris Isomedix Services, Inc. | Dallas District Office | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
September 27, 2010 | CVS Pharmacy, Inc. | New England District Office | New Drug/False Misleading Labeling | December 21, 2010 |
September 27, 2010 | Walgreen Company | Chicago District Office | New Drug/False Misleading Labeling | March 21, 2011 |
September 24, 2010 | Rohrer Dairy Farms Llc | Philadelphia District Office | Illegal Drug Residue | Not Issued * |
September 24, 2010 | Kranenburg Dairy | Dallas District Office | Illegal Drug Residue | Not Issued * |
September 23, 2010 | Mundt & Associates, Inc. | Center for Devices and Radiological Health | Electronic Product Radiation Control | December 15, 2010 |
September 22, 2010 | Quality Plus Products, Inc. | Seattle District Office | Seafood HACCP/Adulterated | Not Issued * |
September 22, 2010 | Defibtech, LLC | New England District Office | CGMP/QSR/Medical Devices/Adulterated | February 02, 2012 |
September 22, 2010 | Spineology, Inc. | Center for Devices and Radiological Health | Investigational Device Exemptions | June 28, 2012 |
September 21, 2010 | Rohr Fish, Inc. | Cincinnati District Office | Seafood HACCP/Insanitary Conditions/Adulterated | Not Issued * |
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