# FDA 483 - Excelvision - November 19, 2024

Source: https://www.keypedia.com/records/483/excelvision/47aa8c53-8ac6-48ec-bf1c-d557a9957469

> FDA 483 for Excelvision on November 19, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Excelvision
- Inspection Date: 2024-11-19
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Exceivision in Annonay, Ardeche, France, revealed significant deficiencies in their drug manufacturing operations. The firm's complaint investigations for product contamination were inadequate, and their aseptic processing procedures, including smoke studies and media fills, lacked proper validation. Additionally, issues were noted with cleaning and disinfection systems, equipment maintenance in aseptic areas, and the absence of second-person review for laboratory environmental monitoring records.

## Related Documents

- [483 - 2023-07-07](https://www.keypedia.com/records/483/excelvision/ce597575-4f9b-4672-b921-3039a5eb2c51)
- [WARNING_LETTER - 2024-11-19](https://www.keypedia.com/records/warning_letter/excelvision/1754c46c-79cc-4412-9689-2588b0be66e3)
- [483 - 2026-01-22](https://www.keypedia.com/records/483/excelvision/17128566-dc20-4dc6-a1f9-21e3e9d1a4a3)

## Related Officers

- [Angelica M. Hernandez](https://www.keypedia.com/people/angelica-m-hernandez/d66d920c-01b6-4770-a1b5-cac9a1790a0e)
- [Eileen A. Liu](https://www.keypedia.com/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)

Company: https://www.keypedia.com/companies/excelvision/b2c65dbb-dd32-400c-80ab-c6feab10deab

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8