Little Rock facility is FDA 21 CFR part 820 compliant and operates in an ISO Class 8 cleanroom
Phillips-Medisize Little Rock facility
Phillips-Medisize, a Molex company, has announced that the Little Rock facility in Arkansas is fully compliant with the current good manufacturing practice (cGMP) regulations enforced by the FDA.
A Molex company, Phillips-Medisize expanded the site in January last year.
The site is FDA 21 CFR part 820 compliant, meaning this 380,000 sqft facility enhances the company's medical manufacturing services with capabilities around moulding, stamping, plating and assembly and 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 an ISO Class 8 cleanroom for medical manufacturing.
Phillips-Medisize has been designing, developing and manufacturing drug delivery devices for decades. The 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.
Matt Jennings, CEO and President of Phillips-Medisize, commented: “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 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.