Europlaz has hosted its latest successful FDA inspection. This achievement demonstrates the company’s commitment to providing its customers with the manufacture, packaging, and labelling of medical devices supplied into the US.
Europlaz
Europlaz's clean room.
The company has completed a £4m investment for new production capabilities and improved clean room capacity; now, Europlaz has reinforced its compliance with the regulatory requirements expected by the FDA. As a result, the company can build on its more than £1.5m of sales in this territory.
“A successful FDA inspection demonstrates that our systems, facility, and processes meet the highest standards,” said Alastair Fry, Regulatory Affairs Manager at Europlaz. “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.”
He continued, “For medical devices sold in the US market, compliance with 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 United States.”
About the FDA inspection
The three-day inspection involved a review of the company’s quality management system, manufacturing processes, documentation, and production facility.
Fry added, “Compliance with 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 it's producing finished devices or components.”
“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 are ready to support the global innovation, compliance, and growth in healthcare and medical devices,” concluded Rory O’Keeffe, Commercial Director of Europlaz.