FDA Inspection 1065219 — Linda L. Chao, PhD
The FDA completed an inspection of Linda L. Chao, PhD on Sep 10, 2018 in San Francisco, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 10, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- San Francisco, CA (United States)
Additional Details
Sponsor-Investigator (S-I)
Citations
| ID | CFR | Description |
|---|---|---|
| 14505 | 21 CFR 812.140(a)(3) | Investigator's subject records inadequate |
| 14508 | 21 CFR 812.140(a)(4) | Investigator record of protocol deviations inadequate |
| 2916 | 21 CFR 812.7(d) | Investigational device represented as safe and /or effective |