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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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2011 Warning Letters

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Warning Letters issued in 2011

 

* 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 April 18, 2011

Letter Issue Date Company Name Issuing Office Subject Close Out Date
April 18, 2011 Oh So Clean, Inc. San Francisco District Office New Drug/Misbranded Not Issued *
April 18, 2011 JD Nelson and Associates, LLC Cincinnati District Office Unapproved New Drug December 06, 2011
April 15, 2011 AGFA healthcare Corp. New England District Office Medical Device Reporting/Misbranded Not Issued *
April 15, 2011 Octapharma AB Center for Biologics Evaluation and Research CGMP Deviations Not Issued *
April 15, 2011 Brinkman Turkey Farms Inc Cincinnati District Office Low Acid Canned Foods Not Issued *
April 15, 2011 Nutro Laboratories, a div of NBTY, Inc. New Jersey District Office Current Good Manufacturing Practice/Dietary Supplements/Adulterated Not Issued *
April 14, 2011 Jensen Tuna Inc New Orleans District Office CGMP for Foods/Seafood HACCP/Adulterated Not Issued *
April 14, 2011 Moehs Cantabra, S.L. Center for Drug Evaluation and Research CGMP/Adulterated August 14, 2012
April 14, 2011 Electric Mobility Corp New Jersey District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
April 13, 2011 Hocean Food Corporation Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
April 13, 2011 Star Food Products, Inc Florida District Office Seafood HACCP/CGMP for Foods/Adulterated September 29, 2011
April 13, 2011 Schindler's Broad Run Cheese House, Inc. Cincinnati District Office CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated August 24, 2011
April 13, 2011 Delta Airlines, Inc. Atlanta District Office Interstate Conveyance Sanitation Regulations Not Issued *
April 13, 2011 Happy Crab Seafood Inc Seattle District Office CGMP for Foods/Seafood HACCP/Adulterated Not Issued *
April 08, 2011 Eidon Incorporated Los Angeles District Office Unapproved New Drug Promotional Claims/Misbranded Not Issued *
April 07, 2011 ChemPacific Corporation Baltimore District Office CGMP for Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
April 07, 2011 Kt Botanicals San Francisco District Office New Drug/Misbranded Not Issued *
April 06, 2011 Omega Nutrition U.S.A., Inc. Seattle District Office New Drugs/Dietary Supplements/Food Labeling/Misbranded December 15, 2011
April 06, 2011 Cache Creek Dairy San Francisco District Office Animals Sale for Slaughter as Food/Adulterated Not Issued *
April 06, 2011 Fresenius Medical Care Holdings, Inc Center for Devices and Radiological Health Device/Adulterated Not Issued *


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