FDA Inspection
ILO Electronic GmbHILO Electronic GmbH – FDA Inspection, Sep 3, 2026
Record Details
This FDA Inspection record concerns ILO Electronic GmbH, with an inspection on September 3, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
View Company Profile
ID · b73f85b2-e205-4366-8352-33095524088e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1334940
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- ISO 13485:2016 Clause 7.3.6Design and development verification plans not adequate
- ISO 13485:2016 Clause 7.3.7Design and development validation plans not documented
- ISO 13485:2016 Clause 7.3.9Procedures to control design and development changes not documented
- ISO 13485:2016 Clause 7.5.9.1Procedures for traceability were 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.