FDA Inspection 1065084 — Odonate Therapeutics, Inc.
The FDA completed an inspection of Odonate Therapeutics, Inc. on Sep 10, 2018 in San Diego, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 10, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- San Diego, CA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7480 | 21 CFR 312.50 | Ensuring compliance with plan and protocol |
| 7507 | 21 CFR 312.52(a) | Transfer of obligations |