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U.S. Department of Health and Human Services

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 April 06, 2010

Letter Issue Date Company Name Issuing Office Subject Close Out Date
March 17, 2010 Chawla, Sant P., M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
March 17, 2010 Orthotic & Prosthetic Lab Inc. Center for Devices and Radiological Health Device/Misbranded Not Issued *
March 17, 2010 Empire Dairy Denver District Office Illegal Drug Residue Not Issued *
March 17, 2010 Tinnitus Control, Inc. Center for Devices and Radiological Health Device/Lacks Annual Registration/Misbranded May 10, 2010
March 17, 2010 Orthotic & Prosthetic Lab, Inc. Center for Devices and Radiological Health Device/Lacks Annual Registration/Misbranded May 10, 2010
March 17, 2010 Vulcon Technologies Inc Center for Devices and Radiological Health Device/Misbranded Not Issued *
March 17, 2010 Tinnitus Control, Inc. Center for Devices and Radiological Health Device/Misbranded Not Issued *
March 17, 2010 KHL Inc Center for Devices and Radiological Health Device/Misbranded May 20, 2010
March 17, 2010 Providence Dairy, LLC Detroit District Office Illegal Drug Residue December 08, 2010
March 16, 2010 Konec Inc. Center for Drug Evaluation and Research Unapproved New Drug/Misbranded March 16, 2011


 

Contact FDA

301-796-8490
FDA's Office of Critical Path Programs
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