[U.S. Food and Drug Administration]

Most Recent Warning Letters

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Most Recent Warning Letters Entered Into Database (Since 5/16/09)
Company Name Date Warning Letter Issued Issuing Office Subject File Response Posted  
Perelandra, LTD
5/19/09
 Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus [PDF]
[HTML]
No
  
Wellness Resources, Inc.
5/19/09
 Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus [PDF]
[HTML]
No
  
NZYMES.COM
5/18/09
 Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus [PDF]
[HTML]
No
  
Dexcel Pharma Technologies Ltd
5/14/09
 Center for Drug Evaluation and Research DDMAC/Promotional Claims False & Misleading/Misbranded [PDF]
[HTML]
No
  
Resolveswineflu.com USA
5/14/09
 Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus [PDF]
[HTML]
No
  
Healthy Choice Naturals
5/12/09
 Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus [PDF]
[HTML]
No
  
Howard Instruments Inc.
5/12/09
 New Orleans District Office CGMP/QSR/Medical Devices/Adulterated [PDF]
[HTML]
No
  
Johnson & Johnson Ps
5/12/09
 Center for Drug Evaluation and Research DDMAC/Promotional Claims False & Misleading/Misbranded [PDF]
[HTML]
No
  
Whole World Botanicals
5/12/09
 Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus [PDF]
[HTML]
No
  
Ageless Herbs
5/11/09
 Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus [PDF]
[HTML]
No
  
VitaCroft, LLP
5/08/09
 Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus [PDF]
[HTML]
No
  
Lupin Limited
5/07/09
 Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/Deviations/Adulterated [PDF]
[HTML]
No
  
Synkem
5/06/09
 Center for Drug Evaluation and Research CGMP for Deviations/Adulterated [PDF]
[HTML]
No
  
Cornerstone Therapeutics, Inc.
5/04/09
 Center for Drug Evaluation and Research DDMAC/Promotional Claims False & Misleading/Misbranded [PDF]
[HTML]
No
  
Rebuilder Medical
5/03/09
 Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus [PDF]
[HTML]
No
  
Amsino Medical USA
4/03/09
 New Orleans District Office CGMP/QSR/Medical Devices/Adulterated [PDF]
[HTML]
No
  
Blackstone Medical Inc.
3/13/09
 New England District Office CGMP/QSR/Medical Devices/Adulterated [PDF]
[HTML]
No
  
Millennium Biotechnology, Inc.
1/12/09
 New York District Office CGMP/QSR/Medical Devices/Adulterated [PDF]
[HTML]
No
  

Warning Letters

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Last Updated on 5/22/2009