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 March 23, 2010
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| March 16, 2010 | Glenmark Pharmaceuticals Inc. | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded | March 16, 2011 |
| March 16, 2010 | Amerilab Technologies, Inc | Minneapolis District Office | Labeling/New Drug/Misbranded | January 03, 2011 |
| March 15, 2010 | 1008 Grinstead Mill Road Dairy | Cincinnati District Office | Illegal Drug Residue | March 20, 2012 |
| March 15, 2010 | Healthy Body Forero | San Juan District Office | New Drug/Labeling/False & Misleading Claims/Misbranded | February 11, 2011 |
| March 12, 2010 | BTL Industries, Inc. | Center for Devices and Radiological Health | Premarket Approval/Misbranded/Adulterated | Not Issued * |
| March 12, 2010 | Medline Industries Inc. | Center for Devices and Radiological Health | Medical Devices/Adulterated/Misbranded | Not Issued * |
| March 12, 2010 | Endogastric Solutions Inc | Seattle District Office | Medical Device Reporting (MDR) Regulation Misbranded/Adulterated | February 14, 2012 |
| March 12, 2010 | Merck & Co Inc. | Center for Veterinary Medicine | New Animal Drug Application | September 13, 2010 |
| March 12, 2010 | Medispec, Ltd. | Center for Devices and Radiological Health | Device/Lacks Premarket Approval Application/Adulterated/Misbranded | October 19, 2010 |
| March 12, 2010 | Advanced Sterilization Products | Los Angeles District Office | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
| March 11, 2010 | Toledo, Charles H., M.D. | Center for Biologics Evaluation and Research | Bioresearch Monitoring Program/IRB | April 06, 2010 |
| March 11, 2010 | Talisman Limited | Baltimore District Office | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated | Not Issued * |
| March 10, 2010 | NY Fish, Inc. | New York District Office | Seafood HACCP/CGMP for Foods/Adulterated | Not Issued * |
| March 10, 2010 | Clearwater Products, LLC | Florida District Office | Medical Devices/Adulterated/Misbranded | Not Issued * |
| March 08, 2010 | Double B Dairy, LLC | Seattle District Office | Illegal Drug Residue | Not Issued * |
| March 08, 2010 | Frischs Commissary | Cincinnati District Office | Seafood HACCP/CGMP for Foods/Adulterated | |
| March 08, 2010 | Lin, Henry, M.D. | Center for Drug Evaluation and Research | Clinical Investigator | Not Issued * |
| March 05, 2010 | Otologics LLC | Center for Devices and Radiological Health | Investigational Device Exemptions (Sponsor) | Not Issued * |
| March 04, 2010 | Sun Technologies, Inc. | Center for Devices and Radiological Health | Tanning Facility/Federal Performance Standard for Sunlamp Products/Misbranded | Not Issued * |
| March 02, 2010 | Perez-Cruet, Miguelangelo J., M.D., M.S. | Center for Devices and Radiological Health | Investigational Device Exemptions (Clinical Investigator) | Not Issued * |
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