Decision Diagnostics Responds to Shasta Technologies FDA Safety Warning Letter
Company Reaffirms Its Categorical Commitment to Stand Behind,
Manufacture and Sell the Safe and Effective GenStrip
LOS ANGELES, CA -- (Marketwired) -- 04/30/14 -- Decision Diagnostics
Corp. (OTCQB: DECN), and its subsidiary Pharma Tech Solutions, the
FDA registered manufacturer and owner/operator for the popular
GenStrip(TM), a medical device specifically designed to work with the
Johnson & Johnson's LifeScan Ultra family of glucose testing meters,
today will comment on the April 29, 2014 FDA issued safety
communication about the quality systems issues at Shasta Technologies
LLC, the former owner/operator of GenStrip. Shasta is no longer
involved with GenStrip.
The company believes that the FDA communication is accurate in its
criticism of the repeated failures of Shasta to comply with minimum
standards of quality procedure and regulatory compliance. Their
continued noncompliance was the motivating factor behind the March
20, 2014 acquisition of the GenStrip Intellectual Property and the
510(k). The existing product supplied by Shasta performed safely and
effectively, met or exceeded its own 510(k) described standards, and
there have been no reported incidents regarding patient safety or
health and it is now under the regulatory control of the company's
PharmaTech subsidiary and is fully compliant with the mandated
quality procedure policies and documentation.
Keith Berman, Principal Executive Officer of DECN, commented, "We
agree with the FDA that Shasta was incapable of properly overseeing
GenStrip manufacturing. That is why our subsidiary, PharmaTech
Solutions, has acquired GenStrip, its marks, and the 510(k). By
virtue of our acquisition, we have assumed all manufacturing and
quality systems responsibilities. Shasta's role in GenStrip has
ended. We are pleased to announce that the Genstrip product has now
been re-branded as, 'PharmaTech GenStrip 50.' GenStrip 50 will be
enclosed in redesigned packaging and will shortly be available on our
customers' shelves. More importantly, GenStrip 50 will continue to be
made in the USA by the same leading diagnostic strip contract
Mr. Berman concluded, "Despite the fact that the issued FDA warning
was directed solely to Shasta Technologies and is wholly their
responsibility, as the acquirers of the technology and Intellectual
Property, Decision Diagnostics and its subsidiary PharmaTech
Solutions has committed to replace every box of GenStrip manufactured
during Shasta's tenure as manufacturer and owner operator. This
guarantee is regardless of where the patient may have purchased the
product, or how any Genstrip seller or distributor may have acquired
the product, its replacement will be honored. Any replaced product
returned to PharmaTech will be destroyed."
Forward Looking Statements:
This release contains forward-looking statements about our business
or financial condition that reflect our assumptions and beliefs based
on information currently available. We can give no assurance that the
expectations indicated by such forward-looking statements will be
realized. There may be other risks and circumstances that we are
unable to predict. When used in this release, words such as
"believes," "expects," "forecasts," "intends," "projects," "plans,"
"anticipates," "estimates" and similar expressions are intended to
identify forward-looking statements, although there may be certain
statements not accompanied by such expressions.
For further information about the Pharma Tech GenStrip 50, please
visit the company's Web Sites: http://www.decisiondiagnostics.com/ or
GenStrip 50 test strips are a product of PharmaTech Solutions, Inc.
and are not manufactured, distributed, endorsed, or approved by nor
associated with LifeScan(R), Inc. a Johnson & Johnson(R) Company,
manufacturers and distributors of the OneTouch(R) Ultra(R) Family of
Meters and OneTouch(R) Ultra(R) test strips.
Decision Diagnostics Corp.
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