# FDA 483 - LABORATOIRES ANIOS AN ECOLAB COMPANY - September 12, 2024

Source: https://www.keypedia.com/records/483/laboratoires-anios-an-ecolab-company/e790bb3e-e125-49d5-bf41-8ba0e6d89d4f

> FDA 483 for LABORATOIRES ANIOS AN ECOLAB COMPANY on September 12, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LABORATOIRES ANIOS AN ECOLAB COMPANY
- Inspection Date: 2024-09-12
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: An FDA inspection of Laboratoires Anios, a drug manufacturer in Sainghin-en-Melantois, France, revealed significant deficiencies in their quality control systems. The firm failed to establish adequate specifications and testing procedures for raw materials and lacked a robust stability testing program for its drug products. These issues raise concerns about the identity, strength, quality, and purity of drugs manufactured and shipped to the U.S.

## Related Officers

- [Joohi Castelvetere](https://www.keypedia.com/people/joohi-castelvetere/2340bef8-5105-4f40-9713-120196b70d82)

Company: https://www.keypedia.com/companies/laboratoires-anios-an-ecolab-company/4ace7408-9319-4a7c-822c-861e4a0608fa

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3