# FDA 483 - Ercros S.A. - December 14, 2018

Source: https://www.keypedia.com/records/483/ercros-sa/fdfd9cc4-526f-4754-98fa-40dfe49d4395

> FDA 483 for Ercros S.A. on December 14, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ercros S.A.
- Inspection Date: 2018-12-14
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Ercros S.A., an active pharmaceutical manufacturer in Aranjuez (Madrid), was inspected by the FDA from December 10-14, 2018. The inspection revealed significant deficiencies across multiple areas, including inadequate investigations into out-of-specification results, insufficient process and rework validation, and issues with equipment cleaning, control system validation, and laboratory procedures. These observations indicate a need for comprehensive improvements in quality control and manufacturing practices.

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## Related Officers

- [Díaz, National Expert](https://www.keypedia.com/people/diaz-national-expert/242ce64a-77ce-4cd8-b198-be95878e37dc)
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Company: https://www.keypedia.com/companies/ercros-sa/adeb63ee-2821-47de-939a-39c363e39854

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321