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 January 18, 2011
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| December 30, 2010 | Dr. Christopher's | Denver District Office | Drug Products/Therapeutic Claims | Not Issued * |
| December 28, 2010 | Pacific Exchange Distributors, Llc | Los Angeles District Office | Seafood HACCP/CGMP for Foods/Adulterated | Not Issued * |
| December 28, 2010 | McGuff Pharmaceuticals Inc. | Los Angeles District Office | Current Good Manufacturing Practice for Finished Pharmaceuticals/Misbranded/Adulterated | April 25, 2012 |
| December 28, 2010 | Novacare, LLC | Denver District Office | Unapproved New Drugs/Misbranded Dietary Supplements | Not Issued * |
| December 23, 2010 | Syneron, Inc | Los Angeles District Office | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)/Misbranded | April 03, 2012 |
| December 22, 2010 | Vistar Corporation | Florida District Office | Seafood HACCP/CGMP for Foods/Adulterated | Not Issued * |
| December 22, 2010 | Abon Biopharm (Hangzhou) Co., Ltd | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | October 16, 2012 |
| December 22, 2010 | Aqueduct Medical, Inc. | San Francisco District Office | Lacks Premarket Approval Application/Adulterated/Misbranded | Not Issued * |
| December 22, 2010 | Heritage Labs International LLC | Kansas City District Office | Premarket Approval/Adulterated/Misbranded | July 14, 2011 |
| December 22, 2010 | Bauer & Hasselbarth Gmbh | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | January 11, 2012 |
| December 22, 2010 | Access Bio, Inc. | New Jersey District Office | Lacks Premarket Approval/Adulterated | Not Issued * |
| December 21, 2010 | Klinge Chemicals Limited | Center for Drug Evaluation and Research | CGMP for Deviations/Adulterated | October 22, 2012 |
| December 21, 2010 | Tico's Mexican Foods, inc. | Denver District Office | Seafood HACCP/Insanitary Conditions/Adulterated | Not Issued * |
| December 21, 2010 | Natural Zing, LLC | Baltimore District Office | Unapproved New Drug Promotional Claims/Misbranded | Not Issued * |
| December 21, 2010 | CIBA Vision Puerto Rico, Inc. | San Juan District Office | CGMP/QSR/Medical Devices/Adulterated | September 14, 2011 |
| December 21, 2010 | Natural Options Corp | Florida District Office | New Drug/Adulterated/Misbranded | Not Issued * |
| December 21, 2010 | Smith & Nephew Orthopaedics Gmbh | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
| December 20, 2010 | Peregrine Surgical Ltd | Philadelphia District Office | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
| December 20, 2010 | Wild Thymes Farm, Inc. | New York District Office | Acidified Foods/Adulterated | Not Issued * |
| December 16, 2010 | Verichem Laboratories, Inc. | New England District Office | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
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