# FDA 483 - SISLEY INDUSTRIE - April 19, 2024

Source: https://www.keypedia.com/records/483/sisley-industrie/e7c47f9d-d498-43fa-9bda-2e3928e12a83

> FDA 483 for SISLEY INDUSTRIE on April 19, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SISLEY INDUSTRIE
- Inspection Date: 2024-04-19
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Francos, an OTC drug manufacturer in Villebarou, France, revealed significant deficiencies in laboratory controls and quality unit procedures. The firm failed to establish scientifically sound specifications and test procedures, leading to inadequate testing for raw materials and finished products. Additionally, the quality unit's responsibilities were not fully followed, resulting in the release of out-of-specification products and a history of inadequate investigations and process validation.

## Related Officers

- [Gretchen L. Trendel](https://www.keypedia.com/people/gretchen-l-trendel/4de8009a-85c5-4a1c-a6c8-53b110b19bee)

Company: https://www.keypedia.com/companies/sisley-industrie/195655bf-d5e6-4d66-85db-b933dabbf9fc

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