FDA Inspection 1205070 — Ponya Therapeutics, LLC
The FDA completed an inspection of Ponya Therapeutics, LLC on May 12, 2023 in Brookhaven, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 12, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Brookhaven, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1418 | 21 CFR 211.42(c)(7) | Quarantined Drug Products Area |
| 4336 | 21 CFR 211.150 | Written distribution procedure |