FDA 483 - Hangzhou Fushan Medical Appliances - March 06, 2014

Hangzhou Fushan Medical Appliances, a medical device contract manufacturer in Hangzhou, China, was issued a one-item FDA Form 483 following an inspection from March 3-6, 2014. The inspection, which focused on Class II Speculum devices, identified an inadequacy in the firm's Nonconformity Control Procedure. Specifically, the procedure failed to address immediate corrective actions and lacked documentation for re-training activities related to defects in nonconforming plastic parts.