Phillips-Medisize has announced that its Little Rock, Arkansas facility is now fully compliant with the Current Good Manufacturing Practice (CGMP) regulations enforced by the Food and Drug Administration (FDA).
Phillips-Medisize, a Molex company, has been designing, developing and manufacturing drug delivery devices for decades. Recently, it has announced that its Little Rock, Arkansas facility is now fully compliant with the CGMP regulations enforced by the FDA.
The facility is FDA 21 CFR part 820 compliant, and as a result, this 380,000-square foot facility enhances Phillips-Medisize’s medical manufacturing services with capabilities around moulding, stamping, plating and assembly. This allows for vertical integration of manufacturing, electronics and connected device solutions all in one site. Additionally, the facility leverages existing dedicated white space along with class 8 cleanroom space for medical manufacturing.
Phillips-Medisize’s capabilities stretch across pharmaceutical, diagnostics and medical device companies by providing a wide range of solutions for both mechanical and connected devices. The organisation aims to provide customers with effective quality systems, risk management approaches and dedicated clinical build sites. They also try to produce drug delivery devices and combination products such as electronic Printed circuit board assembly (PCBA) manufacturing at facilities around the globe.
Matt Jennings, CEO and president of Phillips-Medisize said: “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.”
As a new FDA compliant manufacturing site, the Little Rock facility aims to combine the innovative solutions and knowledge of Molex’s existing electronics production operations, with Phillips-Medisize’s drug delivery and medical device expertise.