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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

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 Healthy Body Forero San Juan District Office New Drug/Labeling/False & Misleading Claims/Misbranded February 11, 2011
March 15, 2010 1008 Grinstead Mill Road Dairy Cincinnati District Office Illegal Drug Residue March 20, 2012
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 Medispec, Ltd. Center for Devices and Radiological Health Device/Lacks Premarket Approval Application/Adulterated/Misbranded October 19, 2010
March 12, 2010 Endogastric Solutions Inc Seattle District Office Medical Device Reporting (MDR) Regulation Misbranded/Adulterated February 14, 2012
March 12, 2010 Advanced Sterilization Products Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
March 12, 2010 Merck & Co Inc. Center for Veterinary Medicine New Animal Drug Application September 13, 2010
March 11, 2010 Talisman Limited Baltimore District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/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 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 *



 

Contact FDA

FDA's Office of Critical Path and Regulatory Science Initiatives

Frank F. Weichold, MD, PhD

Acting Director

Critical Path and Regulatory Science Initiatives

301-796-8187

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