# FDA 483 - Enestia Belgium NV - February 20, 2026

Source: https://www.keypedia.com/records/483/enestia-belgium-nv/0bd5ec3a-19a9-490d-8f72-445f3f7062dd

> FDA 483 for Enestia Belgium NV on February 20, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Enestia Belgium NV
- Inspection Date: 2026-02-20
- Product Type: drugs
- Office Name: Division of Blood Components and Devices
- Summary: 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.

## Related Documents

- [483 - 2026-02-20](https://www.keypedia.com/records/483/enestia-belgium-nv/42d5e169-a8f0-473c-b236-7eb3b4f9c003)
- [483 - 2026-02-20](https://www.keypedia.com/records/483/enestia-belgium-nv/c1c8df52-e524-42b8-8c39-8dd327850c18)

## Related Officers

- [Lewis K. Antwi](https://www.keypedia.com/people/lewis-k-antwi/8ab4f1c7-8b5b-4556-98a4-6edc3bc49470)
- [Peng Zhou](https://www.keypedia.com/people/peng-zhou/ce413ab5-8787-4012-bc8f-9ef55f2c3dc1)

Company: https://www.keypedia.com/companies/enestia-belgium-nv/a04913ee-f2a8-4712-9ab2-39a70a715210

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917