FDA Warning Letter Targets Minnesota Medical Batteries Maker, National Creative Enterprises Inc.
Published: Jul 06, 2011
The U.S. Food and Drug Administration has sent a warning letter to a Minnesota company that makes medical batteries and defibrillator mounts for medical device companies and hospitals. National Creative Enterprises Inc., based in Burnsville, received the FDA warning letter dated June 24 mainly related to improper quality controls, but also for failing to provide a full annual device listing to the FDA as required since 2007. The letter was sent to Nicole Nicklow, chief financial officer at National Creative Enterprises. A call for comment was not immediately returned.