Posted 25 January 2017
By Zachary Brennan
The US Food and Drug Administration (FDA) on Tuesday added Nipro’s Thailand site to a list of companies barred from shipping supplies of medical devices to the US because of a lack of quality.
In this case, FDA will not allow shipments of Nipro Thailand’s piston syringes (with luer lock tip or catheter tip) into the US. Nipro Thailand is the only company or site to be listed on FDA’s Import Alert 89-17 list.
“Under section 501(c) of the Federal Food, Drug, and Cosmetic Act (the Act), a device is adulterated if its quality falls below that which it purports or is represented to possess,” FDA explains on the list, noting it “has collected and analyzed samples of various medical devices which have not met the quality level that they purported or were represented to possess, in accordance with acceptance criteria in a standard or in a manufacturer's Quality System (QS) Regulation acceptance procedure. Devices which do not meet their own established medical device specifications or the quality level they were represented to meet could result in a potential health risk to the end user.”
Nipro Thailand may obtain release of a shipment detained under this import alert by “presenting documentation which establishes that the appearance of a violation has been removed, such as sample analyses performed by an independent testing laboratory demonstrating that each shipment has met the criteria specified in the standard or QS acceptance procedure that the device is represented to meet,” FDA says.
Nipro did not respond to a request for comment.
Import Alert 89-17