FDA 483 - Enestia Belgium NV - February 20, 2026

An FDA inspection of ENESTIA BELGIUM NV (SHARP BELGIUM), a secondary labeling and packaging facility, revealed two significant observations. The firm failed to perform routine equipment inspections according to a written program for critical components used in label verification. Additionally, the inspection found inadequate controls over computer systems, including the use of shared user credentials for labeling machines and incomplete remediation of identified data integrity gaps.