FDA WARNING_LETTER - SEDECAL SA - January 24, 2025

On May 5, 2025, the FDA issued a Warning Letter to Mr. Martinez García of C/Pelaya, 9-13 Pol Industrial Rio De Janeiro, 28110 ALGETE Madrid, Spain, following an inspection from January 20-24, 2025. The inspection revealed that the firm's DX-D 100, DX-D 600, and MobileDiagnost wDR systems are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm's response dated February 14, 2025, was deemed inadequate.

Key violations include: 1. **Failure to adequately establish and maintain CAPA procedures (21 CFR 820.100(a))**: Specifically, CAPA 20/028 for self-propelling DXD100 mobile x-ray units lacked documented risk assessment for affected field units. The firm's proposed procedural revisions and training were noted, but revised procedures, retrospective review, and training documentation were not provided. 2. **Failure to adequately establish and maintain design validation procedures (21 CFR 820.30(g))**: The risk analysis for MobileDiagnost wDR