# FDA 483 - Recipharm Monts - October 18, 2022

Source: https://www.globalkeysolutions.net/records/483/recipharm-monts/a83c3605-dbd3-4083-aab4-aa70216b587a

> FDA 483 for Recipharm Monts on October 18, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Recipharm Monts
- Inspection Date: 2022-10-18
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Recipharm Monts, a sterile drug manufacturer in Monts, France, revealed significant deficiencies in its operations. The firm failed to establish and follow adequate procedures to prevent microbiological contamination, lacked proper validation of aseptic and sterilization processes, and exhibited poor cleaning techniques. Additionally, issues were identified in quality control unit responsibilities, data integrity, environmental monitoring, and the stability testing program.

## Related Documents

- [483 - 2013-02-26](https://www.globalkeysolutions.net/records/483/recipharm-monts/01138d7a-dab5-495d-a5da-6e0f03eb5d1e)
- [483 - 2019-11-12](https://www.globalkeysolutions.net/records/483/recipharm-monts/066bfcb2-5e84-479d-a346-8955e69b23e3)
- [483 - 2019-11-12](https://www.globalkeysolutions.net/records/483/recipharm-monts/8da3ebc9-c75d-42d0-9fd6-150cb677753c)

## Related Officers

- [Drug National Expert](https://www.globalkeysolutions.net/people/sandra-a-boyd/c469103a-0917-407a-b9d1-98273358dfeb)

Company: https://www.globalkeysolutions.net/companies/recipharm-monts/e3b2f0c3-26eb-4020-8127-76127e9e18d6

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