FDA Inspection 1306850 — Mercator Medsystems, Inc.
The FDA completed an inspection of Mercator Medsystems, Inc. on March 11, 2026 in San Leandro, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 11, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- San Leandro, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23216 | ISO 13485:2016 Clause 8.2.2 | Lack of documented justification for not investigating complaint(s) |