FDA Inspection 1196912 — Sina Health Inc
The FDA completed an inspection of Sina Health Inc on January 13, 2023 in Scottsdale, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 13, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Scottsdale, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1541 | 21 CFR 211.125(b) | Examination of issued labels |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |