Phillips-Medisize, a Molex company, announces the Little Rock, Arkansas facility is fully compliant with the Current Good Manufacturing Practice (CGMP) regulations enforced by the FDA.
The facility is FDA 21 CFR part 820 compliant. As a result, this 380,000-square foot facility enhances Phillips-Medisize’s medical manufacturing services with capabilities around molding, stamping, plating and assembly which allows for vertical integration of manufacturing, electronics and connected device solutions all in one site.
The facility also leverages existing dedicated white space along with Class 8 cleanroom space for medical manufacturing.
For decades, Phillips-Medisize has been designing, developing and manufacturing drug delivery devices. Phillips-Medisize’s current end-to-end capabilities serve pharmaceutical, diagnostics and medical device companies with a wide range of solutions for both mechanical and connected devices.
Customers benefit from effective quality systems, risk management approaches and dedicated clinical build sites, as well as the ability to produce drug delivery devices and combination products, including electronic PCBA manufacturing at facilities around the globe.
“We believe most drug delivery devices will benefit from being part of a connected health system. For that reason, we diligently pursue opportunities for lowering the cost of adding connectivity modules to drug delivery devices,” said Matt Jennings, CEO and President of Phillips-Medisize. As a new FDA compliant manufacturing site, the Little Rock facility combines the innovative solutions and knowledge of Molex’s existing electronics production operations with Phillips-Medisize’s proven platform of drug delivery and medical device expertise.
Source: Company Press Release.