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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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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

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
October 15, 2009 Cold Cut Kruise, Inc. [ARCHIVED] Detroit District Office Seafood HACCP/CGMP for Foods/Adulterated May 17, 2011
October 14, 2009 Seaport Fish Company [ARCHIVED] New England District Office Seafood HACCP April 21, 2010
October 14, 2009 J & V Dairy, LLC [ARCHIVED] Seattle District Office Illegal Drug Residue Not Issued *
October 13, 2009 Cerovene, Inc. [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
October 13, 2009 G3 Medical [ARCHIVED] Atlanta District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
October 13, 2009 Dynamic Surgery, Inc. [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated February 28, 2011
October 13, 2009 DAVA Pharmaceuticals, Inc. [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded March 22, 2011
October 13, 2009 Glenmark Pharmaceuticals Inc. USA 10/13/09 [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
October 13, 2009 Lehigh Valley Technologies, Inc. 10/13/09 [ARCHIVED] Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
October 13, 2009 Smith County Memorial Hospital [ARCHIVED] Dallas District Office Mammography Quality Standards Not Issued *
October 13, 2009 Myojo USA, Inc. [ARCHIVED] Los Angeles District Office Acidified Foods/Emergency Permit Control/Adulterated April 03, 2012
October 09, 2009 Lasik Plus [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 09, 2009 Laser Eye Care of California [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 09, 2009 Lasik Vision Institute [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 09, 2009 LCA Vision Inc [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 09, 2009 TLC Laser Eye Centers [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 09, 2009 Philips Healthcare Inc. 10/9/09 [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
October 09, 2009 Pacific Nutritional Foods, Inc. [ARCHIVED] Seattle District Office Low Acid Canned Food Regulation/Adulterated Not Issued *
October 09, 2009 LCA Vision Inc. [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 09, 2009 LasikPlus Vision Center [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 09, 2009 Evergreen Acres [ARCHIVED] Minneapolis District Office Illegal Drug Residue April 29, 2010
October 09, 2009 LasikPlus Vision Center [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 09, 2009 LasikPlus Vision Center [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 09, 2009 Lasik Vision Institute [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 09, 2009 Lasik Vision Institute [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 09, 2009 TLC Laser Eye Center d/b/a TLC Pittsburgh [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 09, 2009 TLC Laser Eye Centers [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 09, 2009 LCA Vision, Inc [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 09, 2009 TLC Laser Eye Centers [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 09, 2009 Lasik Vision Institute [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 09, 2009 LasikPlus [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 08, 2009 www.novalistintegra.com [ARCHIVED] Center for Biologics Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus December 01, 2009
October 08, 2009 Tampa Peanut Distributors [ARCHIVED] Florida District Office CGMP for Deviations/Adulterated July 01, 2010
October 08, 2009 Registry Steaks and Seafood Ltd [ARCHIVED] Chicago District Office Food Labeling/Adulterated/Misbranded March 01, 2010
October 08, 2009 Energy Miracle Enterprises [ARCHIVED] Center for Devices and Radiological Health Medical Devices/Adulterated/Misbranded Not Issued *
October 07, 2009 Multi-Med, Inc. [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated November 09, 2010
October 07, 2009 Symmetry Medical USA, Inc [ARCHIVED] New Orleans District Office CGMP/QSR/Adulterated/Misbranded February 11, 2011
October 07, 2009 Basic American Foods [ARCHIVED] Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
October 06, 2009 Washington Homeopathic Products, Inc. [ARCHIVED] Center for Biologics Evaluation and Research Unapproved New Drug/Misbranded/False or Misleading Not Issued *
October 05, 2009 Crowley Foods Arkport, Division of HP Hood, LLC [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated December 03, 2010
October 05, 2009 Burzynski Research Institute / IRB [ARCHIVED] Center for Drug Evaluation and Research Institutional Review Board (IRB) Not Issued *
October 05, 2009 Phoenix Bio-Tech Corporation [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated/Misbranded Not Issued *
October 05, 2009 East Wind Community, Inc [ARCHIVED] Kansas City District Office Manufacturing Facility/Adulterated/Insanitary conditions June 07, 2010
October 05, 2009 Mystical One LLC [ARCHIVED] New York District Office CGMP for Foods/Juice HACCP/Adulterated Not Issued *
October 02, 2009 Medibo N.V. [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated January 10, 2011
October 02, 2009 CTC Food International Inc [ARCHIVED] San Francisco District Office Seafood HACCP Not Issued *
September 29, 2009 Millipore Corporation [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus February 17, 2010
September 29, 2009 Weartech International Inc. [ARCHIVED] Los Angeles District Office CGMP/QSR/Adulterated/Misbranded April 03, 2012
September 29, 2009 Phoenix Medical Devices, LLC [ARCHIVED] Los Angeles District Office CGMP/QSR/Adulterated/Misbranded Not Issued *
September 28, 2009 Advantage Communications Enterprises [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *

 

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