Inspections, Compliance, Enforcement, and Criminal Investigations
2009 Warning Letters
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Warning Letters issued in 2009
* 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 12, 2010
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
December 31, 2009 | Penumbra, Inc. | San Francisco District Office | CGMP/QSR/Medical Devices/Adulterated/Misbranded | September 21, 2010 |
December 29, 2009 | Crothall Healthcare, Inc. | New Orleans District Office | CGMP/QSR/Medical Devices/Adulterated/Misbranded | July 29, 2011 |
December 28, 2009 | Branan Medical Corp. Inc. | Los Angeles District Office | Premarket Approval/Misbranded/Adulterated | May 17, 2012 |
December 24, 2009 | Micro Current Technology, Inc. | Seattle District Office | Device Lacks Marketing Clearance Approval/Adulterated/Misbranded | Not Issued * |
December 23, 2009 | Arteriocyte Medical Systems Inc | Center for Biologics Evaluation and Research | Device/Lacks Approved Premarket Application/Adulterated/Misbranded | February 17, 2010 |
December 23, 2009 | Grupo Alimentario Del Atlantico Sa "Gralco Sa" | Center for Food Safety and Applied Nutrition | Seafood HACCP/CGMP for Foods/Adulterated | Not Issued * |
December 23, 2009 | Genetics & IVF Institute IRB | Center for Devices and Radiological Health | Institutional Review Board (IRB) | Not Issued * |
December 22, 2009 | Balchem Corporation | Chicago District Office | Current Good Manufacturing Practice Regulation for Finished Pharmaceuticals | August 18, 2010 |
December 21, 2009 | Victus, Inc. | Florida District Office | Medical Device/CGMP Requirements of Quality System Regulation | October 07, 2010 |
December 21, 2009 | Ohm Laboratories, Inc. | New York District Office | CGMP for Finished Pharmaceuticals/Adulterated | Not Issued * |
December 21, 2009 | Paul W. Marks Co., Inc | New England District Office | Seafood HACCP/CGMP for Foods/Adulterated | April 29, 2010 |
December 17, 2009 | Florida Atlantic University IRB | Center for Devices and Radiological Health | Institutional Review Board (IRB) | Not Issued * |
December 16, 2009 | Sushi On a Roll, Inc | Los Angeles District Office | CGMP for Foods/Seafood HACCP/Adulterated | Not Issued * |
December 15, 2009 | Micromed Technology, Inc | Center for Devices and Radiological Health | Medical Device Reporting/Misbranded | Not Issued * |
December 15, 2009 | Awesome Foods, Inc. | Philadelphia District Office | Food Labeling/Misbranded | April 30, 2010 |
December 15, 2009 | Sibley Memorial Hospital | Baltimore District Office | CGMP for Blood & Blood Products/Adulterated | Not Issued * |
December 14, 2009 | Burgos Burgos Corp. | Baltimore District Office | Seafood HACCP/CGMP for Foods/Adulterated | June 08, 2011 |
December 14, 2009 | Indonesia Clove Cigarettes | Center for Tobacco Products | Tobacco Products/Adulterated/Misbranded | Not Issued * |
December 14, 2009 | Langit Bali | Center for Tobacco Products | Tobacco Products/Adulterated/Misbranded | Not Issued * |
December 14, 2009 | JFD Enterprises Inc | Baltimore District Office | CGMP Regulation For Food/Adulterated | June 06, 2011 |
December 14, 2009 | Chuck's Seafoods, Inc. | Seattle District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Not Issued * |
December 14, 2009 | Millenkamp Cattle | Seattle District Office | Illegal Drug Residue | Not Issued * |
December 11, 2009 | Teva Parenterals Medicines, Inc. | Los Angeles District Office | CGMP for Finished Pharmaceuticals/Adulterated | Not Issued * |
December 10, 2009 | Heartsine Technologies Inc | Philadelphia District Office | Device/Misbranded | May 17, 2010 |
December 10, 2009 | LSG SkyChefs DEN 235 | Denver District Office | PHS Act & Control of Communicable Diseases & Interstate Conveyance Sanitation Violations | Not Issued * |
December 10, 2009 | Interacoustics A/S | Center for Devices and Radiological Health | CGMP/QSR/Adulterated/Misbranded | Not Issued * |
December 09, 2009 | M W Laboratories Inc | Atlanta District Office | OTC Drug Labeling/New Drug/Misbranded | Not Issued * |
December 09, 2009 | www.sharco.tv | Center for Biologics Evaluation and Research | Biological Products Standards | Not Issued * |
December 09, 2009 | Freeman Manufacturing Company Corporation | Detroit District Office | Medical Devices/Adulterated/Misbranded | Not Issued * |
December 08, 2009 | Kenshin Trading Corporation | Los Angeles District Office | Premarket Approval/Misbranded/Adulterated | June 28, 2011 |
December 07, 2009 | MyKretek.com | Center for Tobacco Products | Flavored cigarettes/Misbranded/Adulterated | Not Issued * |
December 04, 2009 | San Simeon Incorporated | Denver District Office | Seafood HACCP | August 05, 2011 |
December 04, 2009 | Nestle USA | Center for Food Safety and Applied Nutrition | Labeling/False & Misleading Claims/Misbranded | Not Issued * |
December 03, 2009 | P.M.T. Corp | Minneapolis District Office | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
December 03, 2009 | Ward, John A., M.D. | Center for Drug Evaluation and Research | Clinical Investigator | Not Issued * |
December 03, 2009 | Z-Medica, LLC | New England District Office | CGMP/QSR/Medical Devices/Adulterated | March 01, 2010 |
December 03, 2009 | Nestle Healthcare Nutrition | Center for Food Safety and Applied Nutrition | Labeling/False & Misleading Claims/Misbranded | Not Issued * |
December 01, 2009 | Abruzzino's Italian Bakery, LLC | Baltimore District Office | CGMP Manufacturing, Packing, or Holding Human Food/Adulterated | August 13, 2010 |
December 01, 2009 | Tetracore, Inc. | Baltimore District Office | CGMP/QSR/Medical Devices/Adulterated | August 23, 2010 |
December 01, 2009 | www.secretsofbetterhealth.com dba My Cosmetic Company | Center for Drug Evaluation and Research | Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus | Not Issued * |
December 01, 2009 | Austin Fish Company | Atlanta District Office | Seafood HACCP | Not Issued * |
December 01, 2009 | Village Cannery Of Vermont, Inc. | New England District Office | CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated | March 03, 2010 |
November 30, 2009 | Hyde Park Holistic Center | Center for Food Safety and Applied Nutrition | Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus | Not Issued * |
November 30, 2009 | Aregenius Worldwide LLC | Center for Drug Evaluation and Research | Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus | Not Issued * |
November 30, 2009 | www.bestswinefluvaccine.com | Center for Biologics Evaluation and Research | Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus | Not Issued * |
November 30, 2009 | Aluwe, LLC | Minneapolis District Office | Unapproved New Drug/Misbranded | Not Issued * |
November 30, 2009 | Chaur Fong Inc. dba 888 Food Company | Los Angeles District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Not Issued * |
November 27, 2009 | GDMI, Inc | Dallas District Office | CGMP for Finished Pharmaceuticals/Adulterated/Misbranded | Not Issued * |
November 27, 2009 | ICON Clinical Research, Inc. | Center for Drug Evaluation and Research | Sponsor-Applicant-Monitor-Clinical Research Organization | Not Issued * |
November 27, 2009 | CFM dba Your Deli | Florida District Office | Seafood/HACCP/CGMP for Foods/Adulterated | Not Issued * |
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