Edwards Lifesciences Corp. said Tuesday it received a warning from the Food and Drug Administration over conditions at its Irvine plant.
The FDA’s letter says Irvine-based Edwards wouldn’t receive regulatory approval for devices “reasonably related” to the issues raised in the letter until they are resolved.
The letter comes from an inspection that ended in August and deals with the company’s quality systems, training, documentation and complaint handling in Irvine.
Edwards, in a release, said it’s involved in a broad review of its quality systems.
“We are fully committed to continual improvement of our quality systems and to resolving these issues promptly,” Chief Executive Michael Mussallem said.
Edwards makes heart valves and other products, including catheters and stents.
