Arrotek’s medical device manufacturing facility in Sligo, Ireland has been successfully inspected by the USA’s Food and Drug Administration (FDA). The inspection was officially completed with no actions required.
Catrina Hunter, interim Quality Manager at Arrotek, said: “We are delighted to receive an Establishment Inspection Report from the FDA’s Division of Establishment Support following our recent inspection. The successful inspection is another milestone for Arrotek as we continue with our growth strategy and optimising the services we deliver for our clients.”
An FDA inspector attended Arrotek’s facility in Sligo at the beginning of March 2023. The inspection was a routine baseline QSIT (Quality System Inspection Technique) inspection focusing on the manufacture of a Class II minimally invasive medical device. Therefore, the inspection included all four QSIT subsystems:
- Management controls
- Corrective and preventative action
- Production and process controls
- Design controls
The inspection covered our 50,000 square foot facility which includes all our cleanroom space.
At Arrotek, we provide medical device manufacturing services to customers in addition to design, development, and regulatory services. We specialise in catheters and other minimally invasive medical devices.
Richard McLoughlin, Sales & Marketing Manager said: “This successful FDA inspection is a testament to the hard work, dedication, and expertise of the entire Arrotek team.”