Diabetes Signs – U.S. FDA looking for Snake Oil
The U.S. Food and Drug Administration cited Abbott Laboratories diabetic care unit for falling to establish and maintain adequate procedures for validating device designs.
Other points that the FDA inspector raised in their letter dated 2 July to Abbott Laboratories are;
- The companies failure to address the manufacture of empty blister packs
- Finding scratches on Freestyle Lite test strips
- Abbott’s Freestyle and Navigator blood glucose monitoring products were adulterated
The FDA also mentioned in their letter to Abbott Lab if they fail to promptly correct the manufacturing problems and violations it will lead to future regulatory action.
Abbott Lab spokes person Greg Miley responded with the following.
“Abbott Diabetes Care has taken and continues to take actions necessary to address the items outlined in the letter, and is communicating those actions directly to the agency,”
This deserves a “Big Thank You” to the inspectors of the U.S Food and Drug Administration.
PS. It comforting to know that there are people looking out for the little man and its not all big business.
28/07/2010 – Health group sues FDA over antimicrobial soap
And I thought they were the good guys!
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