483
Delcon SrlDelcon Srl – FDA 483, Mar 24, 2023
Record Details
An FDA inspection of Delcon Srl, a medical device manufacturer in Grassobbio, Italy, revealed two significant observations. The firm failed to adequately establish procedures for complaint handling, specifically regarding investigation timeframes. Additionally, corrective and preventive action activities were not fully documented, as not all relevant complaints were included in a CAPA prior to its closure.
- Person
View Company Profile
ID · ee1d44cb-c5ce-4261-b2ff-4e3c4e105058
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.