FDAnews Device Daily Bulletin

Chinese Devicemaker Mindray Gets Warning Letter on CAPA, Complaints

Jan. 11, 2013
A A
Mindray DS USA, a unit of Chinese device giant Mindray, received an FDA warning letter recently for faulty handling of corrective and preventive actions (CAPA). The eight-observation letter, dated Nov. 29 and posted to the FDA website last week, follows a June 11 to Aug. 16, 2012, inspection of the company’s Mahwah, N.J., facility that ended with a Form 483.
Devices & Diagnostics Letter