The word on FDA from North Carolina

“FDA Ignores Whistleblower” the headline screamed at me as I rushed through the Raleigh Durham International Airport. However when I arrived home in Washington state my local paper hadn’t carried a word about it. Neither had the NY Times. Fair enough, the article from the News Observer, posted under interesting articles on the right, was about the safety of syringes manufactured in North Carolina. But the manufacturing problems- and FDA’s failure to address them, impact the health and safety of us all. Over 100 people became sick from bacteria laden syringes and five people died. North Carolina reader’s have commented on the article and, although most are expressions at rage at FDA, there is one thoughtful comment on the need for better quality control and quality assurance systems and how they make for good business practice.

It will be interesting to see if the new team of Hamburg and Sharfstein can solve some of the systemic problems with FDA inspections. From my review of the article it seems that at least one inspector was attempting to do a good job although she didn’t get to the whistleblower’s issue of the syringe clean room where the bacteria contaminated the syringes. It seems like a management problem to me.

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