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 November 09, 2010
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
October 29, 2010 | CP Pharmaceuticals, Ltd. | Center for Drug Evaluation and Research | CGMP for Finished Pharmaceuticals/Adulterated | July 23, 2012 |
October 28, 2010 | Wright Family Dairy | Atlanta District Office | Animals for Sale for Slaughter as Food/Adulterated | Not Issued * |
October 27, 2010 | Russell C. Davis Planetarium | Center for Devices and Radiological Health | Laser Product Performance Standard | Not Issued * |
October 27, 2010 | Mexicali Cheese Corp. | New York District Office | CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated | Not Issued * |
October 26, 2010 | Bay Island, Inc. | Minneapolis District Office | CGMP for Foods/Adulterated | January 31, 2012 |
October 26, 2010 | Pega Medical Inc. | Center for Devices and Radiological Health | Medical Device Reporting Regulation/Misbranded | Not Issued * |
October 22, 2010 | Pesnusan Cia Ltda | Center for Food Safety and Applied Nutrition | CGMP for Foods/Seafood HACCP/Adulterated | April 21, 2011 |
October 21, 2010 | Hong Chang Corporation | Los Angeles District Office | CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions | Not Issued * |
October 21, 2010 | Nobel Laboratories, LLC | Dallas District Office | Unapproved New Drug Promotional Claims/Misbranded | Not Issued * |
October 21, 2010 | Hanover Foods Corporation | Baltimore District Office | CGMP Regulation For Food/Adulterated | Not Issued * |
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