FDA 483 - Enestia Belgium NV - February 20, 2026

ENESTIA BELGIUM NV (SHARP BELGIUM) in Hamont-Achel, Belgium, underwent an inspection of its secondary labeling and packaging operations. The FDA issued a Form 483 citing deficiencies related to the lack of routine inspection and lifecycle control for critical equipment components. Additionally, the firm failed to exercise appropriate controls over computer systems, including the use of shared user credentials and incomplete data integrity remediation for systems used in packaging and labeling.