# FDA 483 - Kaysersberg Pharmaceuticals SAS - July 07, 2023

Source: https://www.globalkeysolutions.net/records/483/kaysersberg-pharmaceuticals-sas/7ea9666e-82c7-40b1-a9c0-03ebefaa7e8e

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

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## Details

- Record Type: 483
- Company Name: Kaysersberg Pharmaceuticals SAS
- Inspection Date: 2023-07-07
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Kaysersberg Pharmaceuticals S.A.S., a contract manufacturer in Kaysersberg, France, was inspected by the FDA. The inspection revealed significant deficiencies in establishing the accuracy, sensitivity, and reproducibility of test methods. Additionally, the firm failed to exercise appropriate controls over computer systems, leading to concerns regarding data integrity and unauthorized changes to records.

## Related Officers

- [Lori B. Wikstrom](https://www.globalkeysolutions.net/people/lori-b-wikstrom/19d938f7-4a5d-42b9-b2d1-e92cdb63bb0d)

Company: https://www.globalkeysolutions.net/companies/kaysersberg-pharmaceuticals-sas/4f0bba88-dadd-49db-8e17-08165e705377

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d