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 February 09, 2010
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| January 28, 2010 | Nasr, Samya, M.D. | Center for Drug Evaluation and Research | Clinical Investigator | Not Issued * |
| January 28, 2010 | Xian Libang Pharmaceutical Co., Ltd. | Center for Drug Evaluation and Research | CGMP/Manufacturing Facility/Active Pharmaceutical Ingredient | July 07, 2011 |
| January 27, 2010 | OST Medical, Inc. | New England District Office | CGMP/QSR/Medical Devices/Adulterated | July 11, 2012 |
| January 27, 2010 | Kellogg USA | Atlanta District Office | CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Misbranded/Insanitary Conditions | August 15, 2012 |
| January 26, 2010 | www.ayurvediccure.com | Center for Food Safety and Applied Nutrition | Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus | Not Issued * |
| January 26, 2010 | Fertility and Reproductive Medicine Center for Women | Florida District Office | Human Cells, Tissues & Cellular Products | September 29, 2010 |
| January 25, 2010 | Meyer Food Service LLC dba Empire Fish Co | Minneapolis District Office | Seafood HACCP/Adulterated | Not Issued * |
| January 25, 2010 | Venus Foods Inc | Los Angeles District Office | Seafood HACCP/CGMP for Foods/Adulterated | Not Issued * |
| January 22, 2010 | Cardiovascular Diagnostic Image, Inc. | Florida District Office | Mammography Quality Standards Act | Not Issued * |
| January 22, 2010 | Medisound Inc | Florida District Office | Mammography Quality Standards Act | Not Issued * |
| January 19, 2010 | SweetSommer Water Bottling Company, LLC. | Baltimore District Office | Processing and Bottling of Bottled Drinking Water/Adulterated | Not Issued * |
| January 19, 2010 | Crown Health Care Laundry Services, Inc. | New Orleans District Office | CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation | Not Issued * |
| January 19, 2010 | Sun Hang Bean Sprout Inc | Detroit District Office | CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Misbranded/Insanitary Conditions | Not Issued * |
| January 19, 2010 | Cayman Chemical Company | Center for Drug Evaluation and Research | Clinical Investigator (Sponsor) | Not Issued * |
| January 15, 2010 | Cybernet Systems Corp. | Detroit District Office | CGMP/QS/Adulterated/Misbranded | April 15, 2011 |
| January 15, 2010 | McNeil Consumer and Specialty Pharmaceuticals | San Juan District Office | CGMP Regulations for Finished Pharmaceuticals/Adulterated | Not Issued * |
| January 15, 2010 | Baxter Biosciences | Center for Biologics Evaluation and Research | CGMP Deviations | March 22, 2010 |
| January 14, 2010 | Premium Dental, LLC | New Jersey District Office | CGMP/QSR/Medical Devices/Adulterated | February 04, 2011 |
| January 14, 2010 | Sunrise Pharmaceutical, Inc. | New Jersey District Office | CGMP for Finished Pharmaceuticals/Adulterated/Mi sbranded | December 20, 2011 |
| January 14, 2010 | Boonesboro Animal Clinic Corporation | Cincinnati District Office | Illegal Drug Residue | December 06, 2011 |
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