Phillips-Medisize said today that it now has FDA-compliant manufacturing space in the Little Rock, Ark. plant of its parent company, Molex.
The 380,000-square-foot facility is now fully compliant with the Current Good Manufacturing Practice (CGMP) regulations (21 CFR part 820) enforced by the FDA. The plant can now be used for Phillips-Medisize’s medical manufacturing services, including molding, stamping, plating and assembly, allowing for vertical integration of manufacturing, electronics and connected device solutions all in one site. The facility also has dedicated white space along with Class 8 cleanroom space for medical manufacturing.
The plant is FDA-registered to manufacture Cologuard’s colorectal neoplasia DNA methylation and hemoglobin detection system, according to FDA records.
“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 Phillips-Medisize president & CEO Matt Jennings in a news release. “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.”
In February, the company announced it had broken ground on a new manufacturing facility in Hudson, Wis., to support at least 230,000 square feet of manufacturing space for FDA-regulated medical device products.
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