483
Aea SrlAea Srl – FDA 483, Jan 10, 2020
Record Details
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.
View Company Profile
ID · e6c6bd6b-78b3-40e6-910d-8ba804b2ff77
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.