A Medical Device Daily
Cardiovascular device manufacturer Edwards Lifesciences (Irvine, California) reported that the FDA issued it a warning letter concerning conditions at its Irvine, California, facility.
The letter states that Edwards won't receive premarket approvals for devices unless issues raised in the letter are resolved, though the company said it does not expect this matter to have a material impact on its 2007 financial guidance.
Edwards, which makes a range of products, including heart valves, catheters and stent systems, to treat cardiovascular conditions, didn't say which products are made at the Irvine facility.
The warning reportedly stems from an inspection that concluded in August and deals with the company's quality systems, quality systems training, documentation and complaint handling at the Irvine facility. The company said it is involved in a broad review of its quality systems.
"Edwards Lifesciences has a long history of improving the lives of patients with high-quality cardiovascular technologies and we understand the integral role our quality systems play in that mission," said Michael Mussallem, CEO and chairman, in a company statment. "We are fully committed to continual improvement of our quality systems and to resolving these issues promptly."
The company said it has also engaged "independent, external resources to assist in implementing best-in-class quality systems."