Europlaz, a UK manufacturer registered with the US Food and Drug Administration, has successfully passed its latest FDA inspection, highlighting its commitment to supporting US customers with the manufacture, packaging and labelling of medical devices. Fresh from a £4 million investment drive in new production capabilities and cleanroom capacity, the Essex-based company reinforced its compliance with the regulatory requirements expected by the FDA. It means it can build on more than £1.5 million of sales into this important region, with the family-run business now setting its sights on more than doubling this figure over the next two years.
Alastair Fry, regulatory affairs manager at Europlaz, said: “A successful FDA inspection demonstrates that our systems, facility, and processes meet the highest standards. It provides external validation that we operate with the same level of rigour expected of US-based manufacturers, giving existing and potential customers complete confidence in the quality and safety of the products we produce for them.”
Successful inspectionHe continued: “For medical devices sold in the US market, compliance to the FDA’s Code of Federal Regulations is not optional - it is a regulatory requirement. A successful inspection confirms that we can fully support customers in bringing their devices to the USA.”
The three-day inspection involved a review of Europlaz’s quality management system, manufacturing processes, documentation and production facility. Mr Fry added: “Compliance to the FDA’s Code of Federal Regulations ensures that quality is never compromised and that safety is built into every step of our production, whether its producing finished devices or components.”
Operating from its ‘state of the art’ site in Southminster, near Chelmsford, Europlaz’s main focus is on helping medical device and healthcare businesses commercialise new technology. From here, the family-run business has invested £4 million into creating a world-class facility capable of injection moulding, assembly, product validation and access to modern cleanrooms (all ISO Class 7) for the manufacture of Class I and Class II medical devices.
Rory O’Keeffe, Europlaz’s commercial director, concluded: “The successful inspection is recognition of the hard work and commitment of our team, so a massive thank you to them — and to the wider industry — we want to signal that we stand ready to support the global innovation, compliance, and growth in healthcare and medical devices.”