FDA 483 - Aea Srl - January 10, 2020

An FDA inspection of A.E.A Srl, a device manufacturer in Moie de Maiolati, Italy, identified two significant issues. The firm's Device History Records did not consistently demonstrate manufacturing in accordance with the device master record, specifically regarding negative pressure specifications. Additionally, Service Reports were found to be inadequately documented, lacking reasons for service calls and sufficient detail on activities performed.