Ivera Medical Successfully Completes FDA Inspection
(firmenpresse) - SAN DIEGO, CA -- (Marketwired) -- 10/21/14 -- Ivera Medical Corporation is pleased to report that it successfully completed several days of an exhaustive and intensive review by the Food and Drug Administration (FDA) of Ivera's manufacturing practices, quality control and regulatory filings. At the conclusion of the inspection, which was prompted by a complaint filed by a competitor (Catheter Connections), the inspector found that no corrective actions were needed. Ivera recently received a copy of the inspection report from the local FDA District Office confirming that the inspection is now considered officially closed.
"I am pleased with the results of the audit, as we take great pride in ensuring our company operates in compliance with FDA's exacting regulatory requirements and expectations," said Bob Rogers, CEO of Ivera Medical. "Ivera believes Catheter Connections has very little credibility and we were both surprised and offended by their assertions that we were not in compliance with FDA's requirements. The results of this audit are particularly rewarding and we are glad that the record has now been set straight. It is ironic that the inspection was triggered by a complaint from Catheter Connections, as they now find themselves having to explain why their DualCap Dark Blue Male Disinfection Cap has failed a series of disinfection tests conducted by an independent lab."
"We take great pride in helping clinicians work on a significant healthcare problem, and doing so with products made in the USA," said Mr. Rogers. "It is also important to us that we operate conscientiously and with integrity, and the results of this inspection serve as another example that demonstrates Ivera Medical is the leader in its field."
Ivera Medical Corporation, a certified Minority Business Enterprise (MBE), is focused on the design, development, manufacture, marketing and sale of products that help healthcare providers reduce facility-acquired patient infections. Curos, manufactured in Carlsbad, CA, is the first disinfecting cap to be marketed in the U.S. and has received FDA's 510(k) market clearance. For more information about Curos and Ivera Medical, visit the website at
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Datum: 21.10.2014 - 09:00 Uhr
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News-ID 345483
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