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Thursday, May 08, 2014 7:03:28 PM
DECN shepherded the product (genstrip) through its 510k approval with the FDA. That was the reference in the filings.
The inventor/owner/developer of an FDA-regulated device is REQUIRED to have a "Quality System" in place.
Shasta failed to comply with this requirement.
DECN has/had nothing to do with Shasta's failure to meet this requirement. (If you do not know/understand what an FDA-required "Quality System" is, I would suggest you google it).
Since 4/16/14, DECN purchased genstrip outright from Shasta. So, now (and ONLY now) DECN is FDA-required to have a 'Quality System" in place for genstrip.
What you need to know about this is that this does NOT speak to the quality or accuracy of the product. It does serve as an indicator that the product was not being produced under the guidelines of an FDA required "Quality System".
Trust me - if the FDA actually considered genstrip to be a defective product, they would most certainly have mandated a recall...and, they did not.
Berman has said that DECN has the required Quality System in place. I have no reason to doubt him.
Attempts by those who regularly post here for the sole purpose of impugning the company and casting doubt in the minds of its shareholders - are, IMO, purely malicious acts of intentional deception" AND HE IS SPOT ON ... give it till 2015 or just leave
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