FDA Inspection 1258362 — Prodrome Sciences USA, LLC
The FDA completed an inspection of Prodrome Sciences USA, LLC on January 10, 2025 in Temecula, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 10, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Temecula, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 7638 | 21 CFR 312.20(a) | Failure to submit an IND |