Chinese Devicemaker Draws FDA Warning Letter for ENT Devices
The FDA has issued a warning letter to a Chinese devicemaker, Tianjin Bolang Science-Technology Development, listing nine violations for ear, nose and throat (ENT) devices exported to the U.S.
The warning letter followed a March 22 to 30 FDA inspection of the company, which manufactures otoscopes, rigid laryngoscopes and rigid nasopharyngoscopes.
Problems observed during the inspection included inadequate procedures “to ensure only those devices approved for release are distributed,” the agency said.
The FDA also cited the company for lacking customer complaint handling procedures for complaints from its U.S. distributor.