Edwards Lifesciences Gets FDA Warning Letter

Irvine, CA-based Edwards Lifesciences reported that it has received a warning letter from the FDA stemming from a plant inspection that found problems in its quality-control systems, according to Reuters News Service.

The warning letter prevents new-product approvals for devices related to the quality-control issues, which include complaint handling, documentation and systems training, according to the company that is a manufacturer of heart valves.

The problems surfaced during a routine inspection of the company’s Irvine facility in August. Edwards said it is conducting a broad review of its quality systems and has kept the FDA informed of its efforts.

Despite the letter Edwards does not expect any delays to its clinical trials or product launches.

Edwards aims to introduce a next-generation tissue valve, called Magna, in the third quarter of this year and is also seeking a new indication for its LifeStent product for use in a leg artery.