# FDA 483 - SYNAPTIC MEDICAL CORPORATION - March 31, 2026

Source: https://www.keypedia.com/records/483/synaptic-medical-corporation/8a444134-4b4b-4c40-9708-25d8683dfc25

> FDA 483 for SYNAPTIC MEDICAL CORPORATION on March 31, 2026. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: SYNAPTIC MEDICAL CORPORATION
- Inspection Date: 2026-03-31
- Product Type: other
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of Synaptic Medical Corporation in Carlsbad, CA, identified a significant issue regarding the monitoring of an investigational study. The firm failed to ensure proper monitoring, specifically concerning subject eligibility criteria for a protocol, leading to the enrollment of ineligible subjects. This indicates a lapse in clinical trial oversight and adherence to their own monitoring plan.

## Related Officers

- [Jose A. Leyva](https://www.keypedia.com/people/jose-a-leyva/0c0ffdd3-cd41-4e30-bf61-e96f62a58921)
- [Samson O. Oluseye](https://www.keypedia.com/people/samson-o-oluseye/bfe102f5-25cb-4ed9-9e69-2ec5ec0a047f)

Company: https://www.keypedia.com/companies/synaptic-medical-corporation/5adff8ae-4a39-4daa-972c-10585a44b850

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b