Malaysian plant wins FDA approval

Facility is approved to manufacture class III finished devices on behalf of a large tier-one medical OEMs.

One of the Penang, Malaysia facilities operated by contract manufacturer Plexus Corp has received approval from the Food and Drug Administration (FDA), through its premarket approval (PMA) supplement evaluation process, to manufacture class III finished devices on behalf of a large tier-one medical OEMs.

This approval comes following an extensive on-site audit in Penang by the FDA.

Dean Foate, Chief Executive Officer of Plexus, says: "This approval is another significant milestone in our 20 year history of supporting the increasingly global outsourcing requirements of medical device OEMs".

"Plexus has three FDA registered manufacturing facilities in the USA, Mexico and Malaysia, two of which are now approved to manufacture finished class III medical devices".

"Additionally, four of our engineering facilities and six of our manufacturing facilities are also ISO13485:2003 registered".

"With approximately a quarter of our annual revenues coming from product design, supply chain management and manufacturing services for medical device OEMs, Plexus is a leading contract manufacturer for the medical device industry".

Andy Hyatt, Vice President of Plexus' Medical Sector, adds: "We believe Plexus is one of the first contract manufacturers to have an Asian facility with FDA approval to manufacture finished class III medical devices".

"We understand how competitive the medical device market is, and are committed to developing scalable, global solutions that will create a competitive advantage for our customers in their end markets".

"We will continue to broaden our global service offering and expect to be registering additional facilities in Malaysia and the UK with the FDA over the coming year".

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