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 08, 2010
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
May 21, 2010 | AVEVA Drug Delivery Systems, Inc. | Florida District Office | CGMP for Finished Pharmaceuticals/Adulterated | Not Issued * |
May 21, 2010 | Feel Good Natural Health | Center for Drug Evaluation and Research | Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus | Not Issued * |
May 21, 2010 | Dexcom Inc | Los Angeles District Office | Medical Device Reporting/Misbranded | July 15, 2011 |
May 21, 2010 | K. C. Pharmaceuticals Inc. | Los Angeles District Office | CGMP/QSR/Medical Devices/Finished Pharmaceuticals/Adulterated | Not Issued * |
May 21, 2010 | Amigo Mobility International, Inc | Detroit District Office | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
May 21, 2010 | Zone Of Natural Remedies | Center for Drug Evaluation and Research | Unapproved/Unauthorized Products Related to the H1N1 Flu Virus | Not Issued * |
May 21, 2010 | David Montanez Calf Farm | Dallas District Office | Illegal Drug Residue | Not Issued * |
May 20, 2010 | Hyperbaric for Life LLC | Los Angeles District Office | Medical Device Reporting Regulation/Misbranded | July 15, 2011 |
May 20, 2010 | River's Edge Pharmaceuticals, LLC | Atlanta District Office | CGMP for Finished Pharmaceuticals/Adulterated/Misbranded | Not Issued * |
May 17, 2010 | A Simoes Family Dairy | Los Angeles District Office | Illegal Drug Residue | Not Issued * |
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