# FDA 483 - Zach System S.A. - October 25, 2018

Source: https://www.globalkeysolutions.net/records/483/zach-system-sa/0ce3b68f-81a4-4147-834b-093ef620c932

> FDA 483 for Zach System S.A. on October 25, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zach System S.A.
- Inspection Date: 2018-10-25
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Zach System S.A., an API manufacturer in Avrille Cedex, France, revealed deficiencies in laboratory control mechanisms. Specifically, the firm's electronic systems for product analysis lacked unique user access controls and protection against data deletion. These issues were observed with analytical instruments used for finished commercial API batches, indicating potential data integrity concerns.

## Related Officers

- [Scott T. Ballard](https://www.globalkeysolutions.net/people/scott-t-ballard/09b2ae9a-3b30-45bd-bac1-437365e938da)

Company: https://www.globalkeysolutions.net/companies/zach-system-sa/c663917a-2b9d-4375-bc79-2cdd0e280002

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