The FDA has sent a warning letter--largely dealing with improper quality controls--to Burnsville, MN-based National Creative Enterprises, a manufacturer and distributor of battery packs and batteries for hospital and medical equipment and two-way communication applications. The letter, dated June 24, discusses the firm's response to a Form 483 issued at the conclusion of an inspection conducted between December 15, 2010 and March 3, 2011. The agency has determined that the company's response is inadequate.
During their visits, the inspectors determined the devices were adulterated. Among the problems they noted was that there were no written procedures for analyzing, investigating and identifying actions needed to correct quality problems. The agency singles out one incident in which two returned merchandise authorization (RMA) forms from customers reporting that batteries incorrectly had female connectors when the design called for male connectors.
"These RMAs and their respective investigations were not documented or controlled through an established CAPA procedure," the letter states. "There was no evidence to demonstrate that these two RMAs were monitored for CAPA inclusion."
In addition, the letter says the company failed to establish and maintain procedures for acceptance of incoming product. "Specifically, RMA #0101908DN was opened as a result of 75 out of (b)(4) of the (b)(4) Sealed Lead Batteries being returned as 'bad.' This is a "pass-thru" battery, and there was no documentation of acceptance activities for this product when it was received by your firm," the letter states.
National Creative Enterprises' Director of Operations Jennifer Aura told MedCity News that her company is complying with the FDA and "we are implementing such procedures as required within FDA guidelines and time frame."