Inspections, Compliance, Enforcement, and Criminal Investigations
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2009 Warning Letters
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Warning Letters issued in 2009
* 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 January 12, 2010
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| December 31, 2009 | Penumbra, Inc. | San Francisco District Office | CGMP/QSR/Medical Devices/Adulterated/Misbranded | September 21, 2010 |
| December 29, 2009 | Crothall Healthcare, Inc. | New Orleans District Office | CGMP/QSR/Medical Devices/Adulterated/Misbranded | July 29, 2011 |
| December 28, 2009 | Branan Medical Corp. Inc. | Los Angeles District Office | Premarket Approval/Misbranded/Adulterated | May 17, 2012 |
| December 24, 2009 | Micro Current Technology, Inc. | Seattle District Office | Device Lacks Marketing Clearance Approval/Adulterated/Misbranded | Not Issued * |
| December 23, 2009 | Arteriocyte Medical Systems Inc | Center for Biologics Evaluation and Research | Device/Lacks Approved Premarket Application/Adulterated/Misbranded | February 17, 2010 |
| December 23, 2009 | Grupo Alimentario Del Atlantico Sa "Gralco Sa" | Center for Food Safety and Applied Nutrition | Seafood HACCP/CGMP for Foods/Adulterated | Not Issued * |
| December 23, 2009 | Genetics & IVF Institute IRB | Center for Devices and Radiological Health | Institutional Review Board (IRB) | Not Issued * |
| December 22, 2009 | Balchem Corporation | Chicago District Office | Current Good Manufacturing Practice Regulation for Finished Pharmaceuticals | August 18, 2010 |
| December 21, 2009 | Victus, Inc. | Florida District Office | Medical Device/CGMP Requirements of Quality System Regulation | October 07, 2010 |
| December 21, 2009 | Ohm Laboratories, Inc. | New York District Office | CGMP for Finished Pharmaceuticals/Adulterated | Not Issued * |
| December 21, 2009 | Paul W. Marks Co., Inc | New England District Office | Seafood HACCP/CGMP for Foods/Adulterated | April 29, 2010 |
| December 17, 2009 | Florida Atlantic University IRB | Center for Devices and Radiological Health | Institutional Review Board (IRB) | Not Issued * |
| December 16, 2009 | Sushi On a Roll, Inc | Los Angeles District Office | CGMP for Foods/Seafood HACCP/Adulterated | Not Issued * |
| December 15, 2009 | Micromed Technology, Inc | Center for Devices and Radiological Health | Medical Device Reporting/Misbranded | Not Issued * |
| December 15, 2009 | Awesome Foods, Inc. | Philadelphia District Office | Food Labeling/Misbranded | April 30, 2010 |
| December 15, 2009 | Sibley Memorial Hospital | Baltimore District Office | CGMP for Blood & Blood Products/Adulterated | Not Issued * |
| December 14, 2009 | Burgos Burgos Corp. | Baltimore District Office | Seafood HACCP/CGMP for Foods/Adulterated | June 08, 2011 |
| December 14, 2009 | Indonesia Clove Cigarettes | Center for Tobacco Products | Tobacco Products/Adulterated/Misbranded | Not Issued * |
| December 14, 2009 | Langit Bali | Center for Tobacco Products | Tobacco Products/Adulterated/Misbranded | Not Issued * |
| December 14, 2009 | JFD Enterprises Inc | Baltimore District Office | CGMP Regulation For Food/Adulterated | June 06, 2011 |
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