CPSC and FDA Warn Against Using Infant Sleep Positioners Because of Suffocation Risk: Initial Communication
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm227301.htm

Date Issued: Sept. 29, 2010



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FDA NEWS RELEASE

For Immediate Release: Oct. 22, 2010
Media Inquiries: Pat El-Hinnawy, 301-796-4763, patricia.el-hinnawy@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA heightens focus on retail food safety
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm230659.htm


FDA Warning Letters Posted on October 26, 2010
Letter Issue Date ? Company Name ? Issuing Office ? Subject ? Close Out Date ?
October 20, 2010 Lippton, Howard M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
October 20, 2010 Axis Health Care LLC New Orleans District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
October 20, 2010 Scott, David F., M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
October 18, 2010 Bristol-Myers Squibb Company Detroit District Office Infant Formula/Labeling Not Issued *
October 18, 2010 AMAG Pharmaceuticals, Inc. Division of Drug Marketing, Advertising, and Communications Unapproved New Drug Uses/Misbranded Not Issued *
October 15, 2010 Yunnan Hande Bio-Tech. Co. Ltd. Center for Drug Evaluation and Research CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated Not Issued *
October 14, 2010 Irish Acres Dairy LLC Detroit District Office Animals for Sale for Slaughter as Food/Adulterated Not Issued *
October 13, 2010 Bos Dairy LLC Detroit District Office Animals for Sale for Slaughter as Food/Adulterated Not Issued *
October 05, 2010 Tropical Bakery Wholesale Florida District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated Not Issued *
October 05, 2010 Natural Wellness, LLC Florida District Office Unapproved New Drugs/Misbranded Not Issued *
October 05, 2010 Zander Scientific, Inc. DBA Zander IVF, Inc. Florida District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
September 30, 2010 Impact Instrumentation, Inc. New Jersey District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
August 20, 2010 The Standing Company Detroit District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
August 02, 2010 Saputo Cheese USA Inc. Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Misbranded Not Issued *
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Links on this page:

1. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/default.htm
2. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/default.htm
3. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/default.htm
4. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2007/default.htm
5. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2006/default.htm
6. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2005/default.htm
7. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2004/default.htm
8. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2003/default.htm
9. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2002/default.htm
10. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2001/default.htm
11. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2000/default.htm
12. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/1999/default.htm
13. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/1998/default.htm
14. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/1997/default.htm
15. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/1996/default.htm
16. http://www.fda.govhttps://service.govdelivery.com/service/subscribe.html?code=USFDA_63
17. http://www.accessdata.fda.gov/scripts/warningletters/wlAdvancedSearch.cfm
18. http://www.accessdata.fda.gov/scripts/warningletters/wlFilterByCompany.cfm
19. http://www.accessdata.fda.gov/scripts/warningletters/wlFilterByOffice.cfm
20. http://www.accessdata.fda.gov/scripts/warningletters/wlFilterBySubject.cfm
21. http://www.accessdata.fda.gov/scripts/warningletters/wlSearchResult.cfm?company=&_1_issueDt=&_2_issueDt=&office=&subject=&hasResponseLetter=Yes&hasCloseoutLetter=Both&recsPerPageDef=500&Search=Search&errMsg=
22. http://www.accessdata.fda.gov/scripts/warningletters/wlSearchResult.cfm?company=&_1_issueDt=&_2_issueDt=&office=&subject=&hasResponseLetter=Both&hasCloseoutLetter=Yes&recsPerPageDef=500&Search=Search&errMsg=
23. http://www.accessdata.fda.gov/scripts/warningletters/wlSearchExcel.cfm
24. http://www.fda.gov/RegulatoryInformation/FOI/HowtoMakeaFOIARequest/default.htm
25. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm230909.htm
26. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm230345.htm
27. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm230860.htm
28. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm230799.htm
29. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm230796.htm
30. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm230829.htm
31. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm230794.htm
32. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm230798.htm
33. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm230599.htm
34. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm230439.htm
35. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm230612.htm
36. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm230645.htm
37. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm230834.htm
38. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm230608.htm

Page Last Updated: 09/16/2010


GE Recalls Dishwashers Due to Fire Hazard
http://www.cpsc.gov/cpscpub/prerel/prhtml11/11022.html



Infant Sleep Positioners Pose Suffocation Risk
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm227575.htm


Radiation Exposure
http://www.nlm.nih.gov/medlineplus/radiationexposure.html




http://news.sciencemag.org/
sciencemag web site



U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm230799.htm
* Home
* > Inspections, Compliance, Enforcement, and Criminal Investigations
* > Enforcement Actions
* > Warning Letters

Bristol-Myers Squibb Company



Bisphenol A (BPA) Information for Parents
http://www.hhs.gov/safety/bpa/



Bisphenol A (BPA)
Update on Bisphenol A (BPA) for Use in Food: January 2010
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm064437.htm



Brain Basics: Know Your Brain
http://www.ninds.nih.gov/disorders/brain_basics/know_your_brain.htm



CPSC Reminds Parents How to Prevent Halloween Costume and Decoration-Related Injuries
http://www.cpsc.gov/cpscpub/prerel/prhtml11/11026.html



http://www.fertstert.org/
Official Journal of the American Society for Reproductive Medicine




http://www.hhs.gov/
The Department of Health and Human Services web site



Non reply of Dr. Belo to product inquiry subject of complaint accepted
and acted upon by DTI. Evidence is a letter identified as from the Department of Trade and Industry and addressed to said Belo and dated 19 October 2010.






Lax security at SM City Manila
on October 29, 2010. When I entered said building through the entrance beside Pizza Hut restaurant, the guard at said entrance didn't inspect my shoulder
bag/didn't subject said shoulder bag to scanning by metal detector. Said bag was large enough to contain a firearm. After I entered said building,
I entered SM Department store and nobody at said entrance inspected the contents of said bag and didn't subject said bag to scanning with metal detector.
I filled out a complaint form and a person at what was identified as customer service affixed his signature on my copy of said complaint
After I left said store, I went to SM Appliance store but nobody at the entrance to said store inspected said bag or subjected
bag to scanning with metal detector. I purchased products at said store and was issued SM Appliance sales invoice No. 106702.. While I was at said store,
I went to the entire customer area of said store but there was no visible express lane for senior citizens and there was no prominent display of a
sign, etc., regarding privileges for senior citizens. I believe said store violated the Expanded Senior Citizens Act of 2003. Then I entered SM Supermarket
but nobody at the entrance to said store inspected said bag or subjected said bag to scanning with metal detector. I went to the entire customer area of said
store but there was no prominent display of a sign, etc., regarding privileges for senior citizens. I believe said store violated the Expanded Senior Citizens
Act of 2003. I purchased products and was issued SM Supermarket Manila sales invoice bearing serial number 6461512090.