UPDATED BELOW
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.
The letter notes that an inspection occurred between Dec. 15 and March 3, which lead the agency to inform National Creative Enterprises officials that violations need to be corrected. But the company’s responses were deemed inadequate and resulted in the formal warning letter. Specifically, it points out that the company has no established procedure for correcting quality problems noted in returned merchandise authorization forms, no established unit to handle customer complaints and no process to instruct employees how to deal with a product that is not performing to specification, among several other quality-related infractions. National Creative Enterprises has 15 business days to respond.
The company, whose origins date back to 1968, manufactures batteries for a host of companies, according to its website. They include Abiomed, the Massachusetts company that received its own FDA warning letter in June, Stryker and Depuy.
UPDATE: National Creative Enterprises’ Director of Operations Jennifer Aura responded that the company is complying with the FDA and ” we are implementing such procedures as required within FDA guidelines and time frame.”
By Arundhati Parmar
Arundhati Parmar is the Medical Devices Reporter at MedCity News. She has covered medical technology since 2008 and specialized in business journalism since 2001. Parmar has three degrees from three continents - a Bachelor of Arts in English from Jadavpur University, Kolkata, India; a Masters in English Literature from the University of Sydney, Australia and a Masters in Journalism from Northwestern University in Chicago. She has sworn never to enter a classroom again.More posts by Author
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