FDA Inspection
Delfin Technologies LtdDelfin Technologies Ltd – FDA Inspection, Aug 13, 2026
Record Details
This FDA Inspection record concerns Delfin Technologies Ltd, with an inspection on August 13, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Delfin Technologies Ltd
- Inspection Date
- August 13, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · a506cb4f-63ba-4651-be91-fd80655a2921
Inspection Facts
- Inspection number
- 1330796
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- ISO 13485:2016 Clause 4.1.5Inadequate monitoring and control over outsourced processes
- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.3.1Design and development procedures not documented
- ISO 13485:2016 Clause 7.4.3Purchased product verification activities not established or implemented
- ISO 13485:2016 Clause 8.2.6Monitoring and measurement requirements of product characteristics are not met
- ISO 13485:2016 Clause 8.3.1Procedure for nonconforming product not documented
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.