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 February 08, 2012
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
December 30, 2011 | Okamoto Rubber Products Co., Ltd. | Center for Devices and Radiological Health | Medical Device Reporting/Misbranded | June 07, 2012 |
December 30, 2011 | NAImco Inc dba Richmar Inc | New Orleans District Office | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
December 29, 2011 | Sharn, Inc. | Florida District Office | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
December 29, 2011 | Changzhou Jialing Medicine Industry Co Ltd | Center for Drug Evaluation and Research | Failure to Register and List | Not Issued * |
December 28, 2011 | Jang Soo Farm Inc. dba Rainier Sprouts, Inc. | Seattle District Office | CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions | Not Issued * |
December 28, 2011 | Midmark Corporation | Cincinnati District Office | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
December 28, 2011 | Greencore OARS, LLC | New England District Office | Seafood HACCP/CGMP for Foods/Adulterated /Sanitation | Not Issued * |
December 28, 2011 | Natural Health Team | New Orleans District Office | Unapproved New Drug | Not Issued * |
December 28, 2011 | Vaughan Foods Inc. (Allison's Gourmet Kitchen) | Dallas District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Not Issued * |
December 27, 2011 | San-J International, Inc. | Baltimore District Office | CGMP For Manufacturing, Packing, Storage or Installation/Adulterated | Not Issued * |
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