FDA Inspection
LEASEIR TECHNOLOGIES SLULEASEIR TECHNOLOGIES SLU – FDA Inspection, Sep 2, 2026
Record Details
This FDA Inspection record concerns LEASEIR TECHNOLOGIES SLU, with an inspection on September 2, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- LEASEIR TECHNOLOGIES SLU
- Inspection Date
- September 2, 2026
- Product Type
- Medical Devices & Rad Health
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ID · a34666a8-7d56-4df3-bb40-107770f37553
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1336054
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
8- ISO 13485:2016 Clause 4.1.5Inadequate monitoring and control over outsourced processes
- ISO 13485:2016 Clause 7.3.8Design and development transfer procedures not documented
- ISO 13485:2016 Clause 7.4.1Records of supplier (re)evaluation, selection, and monitoring not maintained
- ISO 13485:2016 Clause 7.5.4Records of servicing activities not maintained
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
- ISO 13485:2016 Clause 8.4Data analysis did not include data from monitoring, measurement, other sources
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
- ISO 13485:2016 Clause 8.5.3Preventive action not determined
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