FDA Inspection 1333042 — Starch Medical Inc.
The FDA completed an inspection of Starch Medical Inc. on Aug 26, 2026 in San Jose, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Aug 26, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- San Jose, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23075 | ISO 13485:2016 Clause 6.2(e) | Records of personnel competence not maintained |
| 23219 | ISO 13485:2016 Clause 8.2.2 | Complaint handling records not maintained |