FDA Inspection 1303696 — Helena C. Chang, MD
The FDA completed an inspection of Helena C. Chang, MD on February 20, 2026 in Santa Clara, 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
- February 20, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Santa Clara, CA (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2981 | 21 CFR 812.140(a)(2)(i) | Investigator device accountability inadequate |