483
Eakin Surgical LtdEakin Surgical Ltd – FDA 483, Jul 5, 2018
Record Details
An FDA inspection of Pelican Feminine Healthcare DBA Single Use Surgical in Cardiff, UK, revealed a significant deficiency in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions (CAPA). This indicates a moderate severity issue related to quality management system controls.
View Company Profile
ID · 0c436433-2431-438e-b420-0f9c0c8dad1b
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.