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

Source: https://www.keypedia.com/records/483/enestia-belgium-nv/42d5e169-a8f0-473c-b236-7eb3b4f9c003

> 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: Center for Biologics Evaluation and Research
- Summary: Between February 18 and February 20, 2026, the U.S. Food and Drug Administration (FDA) conducted an inspection of Enestia Belgium NV (operating as Sharp Belgium) at its secondary labeling and packaging facility in Hamont-Achel, Belgium. The inspection resulted in the issuance of a Form 483, which details several significant quality control failures.

The primary issues identified involve inadequate maintenance of critical equipment and poor oversight of computer systems. Specifically, investigators found that the company lacked a written program for the routine inspection and lifecycle management of critical camera components used to verify labeling data and prevent product mix-ups. Additionally, the FDA observed serious data integrity concerns, including the use of shared login credentials by technicians to access labeling machines. The firm also failed to fully resolve previously identified security gaps in its computerized systems, such as incomplete audit trail reviews and inadequate user access controls, yet continued to use these systems for processing finished drug products.

Issued under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, these observations represent the investigators' preliminary findings rather than a final agency decision. Enestia Belgium NV is required to provide a formal response to the FDA, outlining the specific corrective actions they have taken or plan to take to address these deficiencies. Failure to remediate these issues could lead to further regulatory enforcement.

## 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/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d