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 19, 2010
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
June 25, 2010 | AMPAC Fine Chemicals, LLC | San Francisco District Office | CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated | April 25, 2011 |
June 25, 2010 | American Pecan Co. LLC | Dallas District Office | CGMP for Foods/Labeling/Adulterated/Misbranded | Not Issued * |
June 25, 2010 | Pozner, Jason M.D. | Center for Devices and Radiological Health | Investigational Device Exemptions (Clinical Investigator) | Not Issued * |
June 24, 2010 | Thumb Oilseed Producers' Cooperative | Detroit District Office | CGMP Regulation For Food/Adulterated | Not Issued * |
June 24, 2010 | North Memorial Medical Center | Center for Devices and Radiological Health | Institutional Review Board (IRB) | Not Issued * |
June 23, 2010 | Basic Food Flavors, Inc. | San Francisco District Office | CGMP/Foods/Insanitary Conditions | Not Issued * |
June 23, 2010 | Oregon Health & Science University | Seattle District Office | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products | Not Issued * |
June 23, 2010 | Blountys, LLC | Center for Devices and Radiological Health | Premarket Approval/Misbranded/Adulterated | Not Issued * |
June 22, 2010 | Nanjing Pharmaceutical Factory Company Limited | Center for Veterinary Medicine | CGMP/Active Pharmaceutical Ingredient Manufacturing Facility/Adulterated | Not Issued * |
June 22, 2010 | MedCentral Health System | Center for Devices and Radiological Health | Institutional Review Board (IRB) | Not Issued * |
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