# FDA 483 - Cis Bio International - December 16, 2022

Source: https://www.keypedia.com/records/483/cis-bio-international/edda8111-b5c2-4fba-8e1a-11bf8bfeda12

> FDA 483 for Cis Bio International on December 16, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cis Bio International
- Inspection Date: 2022-12-16
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Cis Bio International, a drug manufacturing facility in Saclay, France, was inspected by the FDA. The inspection revealed significant deficiencies across multiple quality system areas, including failures to reject contaminated drug products, inadequate process validation, insufficient annual product reviews, and unvalidated test methods. These issues indicate a lack of robust controls to ensure the identity, strength, purity, and quality of drug products.

## Related Officers

- [Investigator](https://www.keypedia.com/people/nancy-m-espinal/f4494790-6a37-4998-853c-f859a0eb3330)

Company: https://www.keypedia.com/companies/cis-bio-international/8c28b8ec-b608-40d1-ad76-833dd6d4cc0e

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