FDA Inspection 1099869 — Global Blood Therapeutics, Inc.
The FDA completed an inspection of Global Blood Therapeutics, Inc. on August 12, 2019 in South San Francisco, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 12, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- South San Francisco, CA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7459 | 21 CFR 312.57(a) | Records of receipt, shipment, disposition |
| 7632 | 21 CFR 312.6(a) | Required label statement |