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 June 01, 2010
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
May 17, 2010 | Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc. | Los Angeles District Office | CGMP for Medical Devices/Adulterated | Not Issued * |
May 13, 2010 | Jilin Shulan Synthetic Pharmaceutical Co. Ltd. | Center for Drug Evaluation and Research | CGMP for Deviations/Adulterated | May 31, 2012 |
May 12, 2010 | Miller, David L. | New York District Office | Illegal Drug Residue | Not Issued * |
May 12, 2010 | Terry Yon & Associates, Inc./dba Tya Pharmaceuticals | Florida District Office | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated | Not Issued * |
May 12, 2010 | Laboratorios L.O., Oftalmi, C.A. | Center for Drug Evaluation and Research | CGMP for Finished Pharmaceuticals/Adulterated | Not Issued * |
May 12, 2010 | Cogent Solutions Group LLC | Cincinnati District Office | New Drug/Labeling/Misbranded | March 30, 2011 |
May 12, 2010 | CMC Commodity Transport Inc. | Atlanta District Office | Animal Feed/Adulterated with shredded tire chips | Not Issued * |
May 11, 2010 | Artegraft, Inc. | New Jersey District Office | CGMP/QSR/Medical Devices/Adulterated | March 23, 2011 |
May 11, 2010 | Healthy World Distributing | Seattle District Office | Promotional Claims/Misbranded | Not Issued * |
May 11, 2010 | Molteno Ophthalmic Ltd | Center for Devices and Radiological Health | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated/Misbranded | August 22, 2011 |
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