# FDA 483 - SISLEY INDUSTRIE - April 19, 2024

Source: https://www.keypedia.com/records/483/sisley-industrie/59cede77-1fbb-4021-8fdc-3b7e332a3e1a

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

---

## Details

- Record Type: 483
- Company Name: SISLEY INDUSTRIE
- Inspection Date: 2024-04-19
- Product Type: drugs
- Office Name: Foreign - CDER (Non-Bioresearch Monitoring)
- Summary: During an inspection conducted from April 15-19, 2024, the FDA issued a Form 483 to Francos, an OTC drug manufacturer located in Villebarou, France. The inspection revealed significant deficiencies in the company's laboratory controls and quality unit operations, impacting products destined for the U.S. market. Key observations regarding laboratory controls included inadequate testing for contaminants like Burkholderia cepacia complex in raw materials and finished products, especially for (b)(4) containing products. The FDA also noted issues with unrepresentative water sampling points and unvalidated microbiological testing methods. Furthermore, the quality unit failed to adhere to established procedures. Francos released numerous batches of product to the U.S. despite failing critical finished product specifications such as viscosity. Investigations into product failures were deemed inadequate, lacking thorough root cause analysis, and were not closed in a timely manner. Process validation for certain products was found not to be based on sound scientific principles, with retrospective validation methods and releases of batches that failed specifications. These observations indicate a need for Francos to implement comprehensive corrective and preventive actions to ensure its manufacturing processes and quality systems comply with regulatory good manufacturing practices for drug products.

## Related Documents

- [483 - 2024-04-19](https://www.keypedia.com/records/483/sisley-industrie/e7c47f9d-d498-43fa-9bda-2e3928e12a83)

## 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/foreign-cder-non-bioresearch-monitoring/279f5818-f62e-40c9-951c-cfbc7f929fa1