Wednesday, April 23, 2014

Not my bag, baby

From our friends at the FDA, I see that certain urological products have been found to be adulterated because of failure to follow cGMP. I can't quote the entire letter, because I'm pretty sure it will set off your work firewalls, but this excerpt from the warning letter sounds bad:
b.    AMS 800 Post Market Surveillance Report, D007644, Rev. 01, dated 6/6/12, included an action item for further investigation to determine the root cause for a potential increasing trend in complaint rates related to atrophy and cuff malposition/migration.  No investigation was conducted or documented.
I'm just going to point out that "cuff malposition" sounds painful. Man, I hope they have these problems worked out by the time I'm old enough to need these products. There but for the grace of God...

N.B. Do not do image searches for the AMS 700. You've been warned. 

1 comment:

  1. Images?!?! Whatever. It's the videos that will really have you clutching certain body parts.

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