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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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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

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
April 21, 2011 Regional Medical Center [ARCHIVED] Cincinnati District Office CGMP for Blood & Blood Components & Finished Pharmaceuticals/Adulterated December 20, 2011
April 20, 2011 Zevex International, Inc. [ARCHIVED] Denver District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded November 30, 2011
April 20, 2011 Tomaso's Specialty Foods [ARCHIVED] San Francisco District Office Food Labeling/Misbranded Not Issued *
April 20, 2011 Diaspora Tea & Herb dba Rishi Tea [ARCHIVED] Minneapolis District Office New Drugs/Unauthorized NutrientContent February 03, 2012
April 20, 2011 Triple A Services, Inc. [ARCHIVED] Chicago District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
April 20, 2011 Electrostim Medical Services Inc. [ARCHIVED] Center for Devices and Radiological Health Adulterated Device/Misbranding/Quality Control July 20, 2011
April 20, 2011 ASI Medical, Inc. [ARCHIVED] Denver District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated March 23, 2012
April 19, 2011 Durst Brothers, Inc. [ARCHIVED] Minneapolis District Office Illegal Drug Residue August 09, 2011
April 19, 2011 BIO LAB-ST. JOSEPH CORP [ARCHIVED] San Juan District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
April 19, 2011 BNB MEDICAL CO., LTD. [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
April 18, 2011 Lifetech Resources LLC [ARCHIVED] Los Angeles District Office Promotional Claims/New Drug/Misbranded Not Issued *
April 18, 2011 Tec Laboratories Inc [ARCHIVED] Seattle District Office New Drug/Misbranded Not Issued *
April 18, 2011 Oh So Clean, Inc. [ARCHIVED] San Francisco District Office New Drug/Misbranded Not Issued *
April 18, 2011 Dr G H Tichenor Antiseptic Company [ARCHIVED] New Orleans District Office New Drug/Misbranded December 27, 2013
April 18, 2011 JD Nelson and Associates, LLC [ARCHIVED] Cincinnati District Office Unapproved New Drug December 06, 2011
April 18, 2011 Bonaterra Products, Inc. [ARCHIVED] Los Angeles District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated Not Issued *
April 18, 2011 Medical Positioning Inc. [ARCHIVED] Kansas City District Office CGMP/QSR/Adulterated/Misbranded Not Issued *
April 18, 2011 Bionetek Corporation [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
April 18, 2011 Refine, USA, LLC [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
April 15, 2011 Octapharma AB [ARCHIVED] Center for Biologics Evaluation and Research CGMP Deviations Not Issued *
April 15, 2011 AGFA healthcare Corp. [ARCHIVED] New England District Office Medical Device Reporting/Misbranded Not Issued *
April 15, 2011 Nutro Laboratories, a div of NBTY, Inc. [ARCHIVED] New Jersey District Office Current Good Manufacturing Practice/Dietary Supplements/Adulterated Not Issued *
April 15, 2011 Brinkman Turkey Farms Inc [ARCHIVED] Cincinnati District Office Low Acid Canned Foods Not Issued *
April 14, 2011 Moehs Cantabra, S.L. [ARCHIVED] Center for Drug Evaluation and Research CGMP/Adulterated August 14, 2012
April 14, 2011 Electric Mobility Corp [ARCHIVED] New Jersey District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
April 14, 2011 Jensen Tuna Inc [ARCHIVED] New Orleans District Office CGMP for Foods/Seafood HACCP/Adulterated December 13, 2011
April 13, 2011 Delta Airlines, Inc. [ARCHIVED] Atlanta District Office Interstate Conveyance Sanitation Regulations Not Issued *
April 13, 2011 Schindler's Broad Run Cheese House, Inc. [ARCHIVED] Cincinnati District Office CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated August 24, 2011
April 13, 2011 Hocean Food Corporation [ARCHIVED] Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
April 13, 2011 Happy Crab Seafood Inc [ARCHIVED] Seattle District Office CGMP for Foods/Seafood HACCP/Adulterated Not Issued *
April 13, 2011 Star Food Products, Inc [ARCHIVED] Florida District Office Seafood HACCP/CGMP for Foods/Adulterated September 29, 2011
April 08, 2011 Eidon Incorporated [ARCHIVED] Los Angeles District Office Unapproved New Drug Promotional Claims/Misbranded Not Issued *
April 07, 2011 Kt Botanicals [ARCHIVED] San Francisco District Office New Drug/Misbranded Not Issued *
April 07, 2011 ChemPacific Corporation [ARCHIVED] Baltimore District Office CGMP for Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
April 06, 2011 Fresenius Medical Care Holdings, Inc [ARCHIVED] Center for Devices and Radiological Health Device/Adulterated Not Issued *
April 06, 2011 Chesapeake Crab Connection Co [ARCHIVED] Philadelphia District Office CGMP for Foods/Seafood HACCP/Adulterated/Misbranded October 06, 2011
April 06, 2011 Sometech Incorporated [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
April 06, 2011 Omega Nutrition U.S.A., Inc. [ARCHIVED] Seattle District Office New Drugs/Dietary Supplements/Food Labeling/Misbranded December 15, 2011
April 06, 2011 Cache Creek Dairy [ARCHIVED] San Francisco District Office Illegal Drug Residue Not Issued *
April 05, 2011 UROMATRIX Medical Systems (A Pos-T-Vac Medical Company) [ARCHIVED] Atlanta District Office Premarket Approval/Misbranded/Adulterated Not Issued *
April 04, 2011 Meditherm Inc. [ARCHIVED] Center for Devices and Radiological Health False & Misleading Claims/Misbranded Not Issued *
April 01, 2011 Chantel's Cakes & Pastries [ARCHIVED] Baltimore District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated October 17, 2011
April 01, 2011 Del Bueno [ARCHIVED] Seattle District Office Adulterated Food Not Issued *
March 31, 2011 HWW Enterprise Group [ARCHIVED] Atlanta District Office Labeling/Therapeutic Claims Not Issued *
March 31, 2011 Proportional Technologies, Inc [ARCHIVED] Dallas District Office Postion Emission Tomography (PET)/Adulterated August 17, 2012
March 31, 2011 Sam Hak Food Corp [ARCHIVED] New York District Office CGMP for Foods/Seafood HACCP/Adulterated August 16, 2011
March 30, 2011 AloeElite [ARCHIVED] Florida District Office New Drug/Misbranded Not Issued *
March 30, 2011 Ningbo Smart Pharmaceutical Co. Ltd. [ARCHIVED] Center for Drug Evaluation and Research CGMP/Adulterated Not Issued *
March 29, 2011 Sanuki Kanzume Co [ARCHIVED] Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated June 30, 2011
March 28, 2011 ARC Medical Supplies (Beijing) Co., Ltd. [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated May 08, 2015

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