Planet Innovation (PI) is pleased to announce that our Irvine, California facility has successfully completed a United States Food and Drug Administration (FDA) audit, conducted under the latest QMSR framework, receiving a No Action Indicated (NAI) classification.
The FDA inspectors conducted a thorough audit of our operational methods, focusing on all aspects of our operations, including quality systems, risk management and production processes. This result demonstrates PI’s commitment to maintain the most stringent quality requirements for the manufacture of regulated medical devices and reflects the strength of our global Quality Management System (QMS).
This inspection follows a previously successful FDA audit of our Box Hill development facility in Australia, further demonstrating PI’s consistent, global commitment to regulatory excellence. Combined with regular audits from notified bodies and clients, these results give our clients confidence that PI operates to the same high standards across all its international facilities.
For MedTech companies navigating the complex path to the US market, choosing the right development and manufacturing partner is critical. A clean FDA audit record is one of the clearest signals that a partner has the systems, processes, and people in place to manufacture regulated products reliably and compliantly, reducing risk and accelerating the path to market.
Christine Gibson, PI’s Global Quality Director, said, “Our ISO 13485-certified QMS underpins everything we do, and audits like this one validate that our quality systems are not just well-documented, but well-practiced. We’re proud of this achievement and grateful to the entire PI team whose commitment to quality makes results like this possible. Quality is something we live and breathe every day. It’s something that we build into all our processes, so we deliver for our end customers.”
PI’s specialized capabilities span the full product development lifecycle, from early-stage engineering and design for manufacture, through to commercial-scale production of regulated medical devices.
