483
Cefla s.cFDA 483 - Cefla s.c - July 20, 2018
Discuss this record with AI
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.
Record Details
Cefla s.c, a manufacturer in Verona, Italy, was inspected by the FDA from July 9-20, 2018. The inspection revealed that the firm failed to adequately document design verification results in the design history file. This indicates a deficiency in their quality system regarding design controls.
Open in Dashboard
ID · c416adcc-1747-4053-b8ab-b3eec7f1a0e2