RE: [IP] Disetronic/FDA matter
-- On Sat 08/02, < email @ redacted > wrote:
Subject: [IP] Disetronic/FDA matterInasmuch as the Swiss plant operated under
ISO9003 standards and they make the biggest seller in greater Europe, seems to
me that the FDA is making a mountain out of a molehill.
Thing about the FDA letter (which I STILL have not received...) is that you
shouldn't get scared by it (like the FDA probably hopes you would be...) and
have a good one-on-one with your nearest area Disetronic rep. This company is
really committed to good customer service and they mean business. Just
myhonestopinion. YMMV, of course. Sandy
My stepdaughter has a Disetronic (can't remember which one right off the top of
my head since she is 19 and lives in another state) but my husband and I were
concerned enough to find out about this once I found out about the embargo. She
is still in college so we carry her on our medical. Anyway, I happened across a
copy of the FDA letter to Disetronic and printed it out so my husband can read
it. Now, a little background. My husband is a lead engineer in a nuclear power
plant and is use to dealing with federal regulations on a daily basis. So when I
handed him the letter and I heard, *Oh my God* coming from him, I knew we had a
problem. You see, even if it is ONLY a paperwork snafu, it has to be cleared up
according to FDA standards. The FDA has taken too much flack in recent years for
them to be slack now. After letting some meds get approved too soon and cause
problems and then have to be pulled from the market...Baycol and Rezulin, to
name two right off the top of my head
. And Disetronic is not being cooperative from the sound of the letter.
So if you would like to read the letter for yourself (if you haven't already),
here is a link to the pdf file:
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