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 October 07, 2010
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
September 30, 2010 | O'Barr, Thomas Jr., M.D. | Center for Drug Evaluation and Research | Clinical Investigator | Not Issued * |
September 30, 2010 | Qualiphar Nv | Center for Drug Evaluation and Research | CGMP for Finished Pharmaceutical/Adulterated | Not Issued * |
September 30, 2010 | Impact Instrumentation, Inc. | New Jersey District Office | CGMP/QSR/Medical Devices/Adulterated/Misbranded | Not Issued * |
September 29, 2010 | Snow, Lamar L. M.D. | Center for Drug Evaluation and Research | Clinical Investigator | Not Issued * |
September 29, 2010 | Newberry Farms, LLC | Detroit District Office | Animal Sale for Slaughter as Food/Adulterated | December 10, 2010 |
September 29, 2010 | Kyowa Hakko Kogyo Co., Ltd. | Center for Drug Evaluation and Research | CGMP for Deviations/Adulterated | January 19, 2012 |
September 28, 2010 | St. Jeans Cannery Ltd. | Center for Food Safety and Applied Nutrition | Deviations From Low Acid Canned Food Regulation/Adulterated | Not Issued * |
September 28, 2010 | Telledant LLC | Center for Food Safety and Applied Nutrition | Dietary Supplement/Labeling False and Misleading/Misbranded | Not Issued * |
September 27, 2010 | Nexgen Pharma Inc | Los Angeles District Office | CGMP for Finished Pharmaceutical/Unapproved New Drugs/Adulterated | Not Issued * |
September 27, 2010 | Johnson & Johnson Consumer Group of Companies, Inc. | New Jersey District Office | New Drug/False Misleading Labeling | November 23, 2010 |
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