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 June 01, 2010
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
March 26, 2010 | Estrella Food Products, Inc. | San Juan District Office | Food Labeling/Insanitary Conditions/Adulterated/Misbranded | Not Issued * |
March 26, 2010 | Liquid Manufacturing, L.L.C. | Detroit District Office | Acidified Foods/Adulterated | January 07, 2011 |
March 26, 2010 | Pierre Fabre Medicament Production | Center for Drug Evaluation and Research | CGMP for Finished Pharmaceuticals/Adulterated | August 17, 2011 |
March 25, 2010 | Today's Temptations, Inc. | Chicago District Office | Food Labeling/Misbranded | Not Issued * |
March 25, 2010 | 3CPM Company Inc | Baltimore District Office | CGMP/QSR/Medical Devices/Adulterated | December 13, 2010 |
March 24, 2010 | Roxy Trading Inc | Los Angeles District Office | Adulterated Food | Not Issued * |
March 23, 2010 | Simplydelicious | Denver District Office | CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions | January 19, 2011 |
March 23, 2010 | Dornier Medtech America, Inc. | Center for Devices and Radiological Health | Premarket Approval/Adulterated/Misbranded | Not Issued * |
March 18, 2010 | Paragon Dx, LLC | Center for Devices and Radiological Health | Premarket Approval/Misbranded/Adulterated | May 11, 2010 |
March 17, 2010 | James P. Johnston, CO, dba Midwest Ocular Prosthetics | Center for Devices and Radiological Health | Device/Misbranded, | Not Issued * |
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