FDA Inspection 1199304 — Reveragen Biopharma Inc.
The FDA completed an inspection of Reveragen Biopharma Inc. on March 6, 2023 in Rockville, MD. 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
- March 6, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Rockville, MD (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7409 | 21 CFR 312.53(b) | Shipment to unauthorized persons |
| 7453 | 21 CFR 312.56(b) | Investigator non-compliance |