FDA Inspection
Synaptive Medical IncSynaptive Medical Inc – FDA Inspection, Jan 23, 2025
Record Details
This FDA Inspection record concerns Synaptive Medical Inc, with an inspection on January 23, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
View Company Profile
ID · da7070de-a367-46cb-98f3-14e5944a028d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1258938
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
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.