# FDA 483 - Fareva Amboise - September 16, 2025

Source: https://www.keypedia.com/records/483/fareva-amboise/0557bbe5-f18a-4568-925b-1373efa49df3

> FDA 483 for Fareva Amboise on September 16, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fareva Amboise
- Inspection Date: 2025-09-16
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Fareva Amboise, a sterile and non-sterile drug manufacturer in Poce Sur Cisse, France, was cited for significant deficiencies during an FDA inspection. Observations included inadequate aseptic process validation, poor aseptic techniques, ineffective cleaning and maintenance of equipment, and insufficient production and process controls. Furthermore, the firm demonstrated a lack of data integrity controls, inadequate environmental monitoring, and incomplete batch and master production records.

## Related Documents

- [483 - 2018-05-25](https://www.keypedia.com/records/483/fareva-amboise/db4ab0c8-17a5-421f-8a0a-a9247c322ddc)
- [483 - 2025-09-16](https://www.keypedia.com/records/483/fareva-amboise/ef611832-7428-4ff3-887d-a9a09e0c4322)

## Related Officers

- [Vivin George](https://www.keypedia.com/people/vivin-george/0b0ee298-a577-4bee-b18e-42da0c3bb148)
- [Investigator](https://www.keypedia.com/people/karen-a-briggs/3e77d364-25ea-48c7-87f4-36f3e170bfb5)
- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)

Company: https://www.keypedia.com/companies/fareva-amboise/4d8ebbcc-2e13-4584-b144-63aa8191bc92

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