FDA Inspection 1266530 — RNA Bio/Pharma Inc
The FDA completed an inspection of RNA Bio/Pharma Inc on April 11, 2025 in Chelan, WA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 11, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chelan, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1928 | 21 CFR 211.166(c)(1) | Homeopathic drugs, assessment of stability |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |