FDA Inspection
ADONAI TECHNOLOGIES LLCADONAI TECHNOLOGIES LLC – FDA Inspection, Feb 6, 2026
Record Details
This FDA Inspection record concerns ADONAI TECHNOLOGIES LLC, with an inspection on February 6, 2026, issued by the Cincinnati District Office, covering medical devices & rad health.
- Company
- ADONAI TECHNOLOGIES LLC
- Inspection Date
- February 6, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 01169782-f80d-4c70-a5b7-3f212c7b6c36
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1301850
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.4.1Criteria for the evaluation and selection of suppliers not established
- ISO 13485:2016 Clause 7.5.1Production controls not adequate
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.