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Re: [IP] Re: Disetronic D-Tron Plus freebees



> >Just my opinion.... Roche/Disetronic is a fine company as are its
> >competitors. WAS a fine company, the operative word unfortunately is
> >WAS
> imo.>Roche/Disetronic deserves better treatment from the FDA.  


> Do you have
> some special insight that the rest of us have not been privy to?  Or is
> this opinion based on their corporate donations to IP?  As a Customerof
> Disetronic Medical Systems since 1999 I have seen little but a sharp
> downwardtrend in their service and communications to customers.Nothing
> has surfaced in the years since the FDA importation ban to counter
> thecharges of lax manufacturing by Disetronic.  If anything, the
> oppositehas occurred as Disetronic has had to recall many of its
> consumable items (since the FDA importation ban)and as in the case of
> D-TronPlus they used nothing more than surface glue to attach the
> silicon buttonguides to the pump's surface.

the problems that Disetronic have been having with the FDA are no 
secret and have been posted to this list several times. As best as I 
can reconstruct the issue it is as follows (I'm no expert, so someone 
step in and correct any inconsistencies I introduce): The problem stems 
from a disagreement about paperwork and their manufacturing process 
several years ago. The EU regulatory body and the FDA have differing 
rules on the manufacturing and tracking process for pumps. The 
HTron/Dtron series pumps were manufactured the "old fashioned" way by 
craftsman, much like a fine swiss watch. The FDA dictates that an 
automated line be use where each mfg step is done in the same fashion. 
This eventually led to Disetronic being barred by the FDA from selling 
product in the US. Along comes the Spirit pump. This pump is 
manufactured in a manner which as I understand it is in full compliance 
with the FDA rules. The FDA has inspected the new mfg facility and as 
far as I know has not said there are any problems. Neither have the 
agreed to let D proceed with selling the Spirit in the US. In addition, 
I've heard rumors that some heated words were exchanged at high levels 
between D and the FDA. The net result is that the FDA has not issued a 
finding on their inspection conducted man MONTHS ago. Bottom line, this 
has been going on for several years and I believe it is "payback" by 
someone in the FDA for a grudge against D..... but.... that's just my 
opinion.

Michael
.
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