# FDA 483 - Excelvision - July 07, 2023

Source: https://www.keypedia.com/records/483/excelvision/ce597575-4f9b-4672-b921-3039a5eb2c51

> FDA 483 for Excelvision on July 07, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Excelvision
- Inspection Date: 2023-07-07
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Excelvision, a drug manufacturer in Annonay, France, from June 29 to July 7, 2023, revealed significant deficiencies in aseptic processing. The firm's investigations into unexplained discrepancies and mold contamination were inadequate, and its cleaning, disinfection, and environmental monitoring systems were found to be deficient. These issues indicate a high risk of microbiological contamination for sterile drug products.

## Related Documents

- [483 - 2024-11-19](https://www.keypedia.com/records/483/excelvision/47aa8c53-8ac6-48ec-bf1c-d557a9957469)
- [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

- [Consumer Safety Officer](https://www.keypedia.com/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)

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

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1