# SEDECAL SA – FDA 483, Jan 24, 2025

Source: https://www.keypedia.com/records/483/sedecal-sa/4fc2e96f-041d-4f53-b91e-afc3cd1d11db

> FDA 483 for SEDECAL SA on January 24, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SEDECAL SA
- Inspection Date: 2025-01-24
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of SEDECAL SA, a medical device and electronic product manufacturer in Algete, Madrid, revealed significant deficiencies in their quality system. The firm was cited for inadequate corrective and preventive action procedures, incomplete risk analysis for life-threatening hazards, and failure to implement written Medical Device Report (MDR) procedures. Additionally, a mobile x-ray system was certified without proper testing documentation, indicating serious compliance issues that could impact patient safety.

## Related Documents

- [WARNING_LETTER - 2025-01-24](https://www.keypedia.com/records/warning_letter/sedecal-sa/1757da25-4869-4b06-be44-8b1fb0adb2f0) — date: January 24, 2025

## Related Officers

- [Investigator](https://www.keypedia.com/people/janet-pulver/d46b01cd-8c3d-4a54-bb91-843e0f94de89)

Company: https://www.keypedia.com/companies/sedecal-sa/3387a6b2-7f4d-41e6-bf53-6174595c4216

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8