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Talk to a SpecialistTalk to a SpecialistSedecal S.A., a Spanish manufacturer of diagnostic X-ray devices (DX-D 100, DX-D 600, and MobileDiagnost wDR systems), failed to comply with current good manufacturing practice requirements under the Quality System regulation. The company inadequately established and maintained corrective and preventative action (CAPA) procedures, specifically failing to document a proper risk assessment for mobile X-ray units that were reported to self-propel and crash into control panels or nearly strike patients. This manufacturing deficiency rendered the devices adulterated under federal law, with the violations identified during an FDA inspection conducted January 20-24, 2025.