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 July 06, 2010
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| June 21, 2010 | Beckman Coulter Inc. | Center for Devices and Radiological Health | Premarket Approval/Misbranded | Not Issued * |
| June 21, 2010 | Lamberts Inc | New Orleans District Office | Good Manufacturing Practices for Food/Adulterated/Insanitary Conditions | Not Issued * |
| June 21, 2010 | Alphatec Spine, Inc. | Los Angeles District Office | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated/Misbranded | September 28, 2011 |
| June 21, 2010 | Cranial Solutions | New Jersey District Office | CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation | June 05, 2012 |
| June 21, 2010 | Coldstream Farms L.L.C. | Seattle District Office | Animal Sale for Slaughter as Food/Adulterated | Not Issued * |
| June 21, 2010 | Corepharma LLC | New Jersey District Office | Current Good Manufacturing Practice Regulation for Finished Pharmaceuticals | Not Issued * |
| June 18, 2010 | BENEV Company Inc | Los Angeles District Office | Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated | Not Issued * |
| June 17, 2010 | Cti Science Inc | Cincinnati District Office | Dietary Supplement/Labeling False and Misleading/Misbranded | March 13, 2012 |
| June 17, 2010 | Hostetler, Atlee W. | Cincinnati District Office | Illegal Drug Residue | November 29, 2011 |
| June 16, 2010 | Cruz Perez Hermanos S.A. | Center for Food Safety and Applied Nutrition | Low Acid Canned Food Regulation/Adulterated | November 04, 2010 |
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