EP Medsystems Gets FDA Warning Letter

West Berlin, NJ-based EP Medsystems has reported that it received a warning letter from the FDA about its quality system regulations, according to the Associated Press.

In its last quarterly financial report, the company said it recalled a product, but did not say which one.  Because of the recall the FDA audited the company’s West Berlin, NJ plant.

EP Medsystems is a manufacturer of products to diagnose and treat irregular heartbeats.

The warning letter asks for a written plan outlining steps to address issues identified in the letter.

EP said it intends to promptly respond to the FDA.