FDA Inspection 1216308 — EONE Laboratories
The FDA completed an inspection of EONE Laboratories on Aug 30, 2023 in Yeonsu District. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 30, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Yeonsu District (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 12437 | 21 CFR 1271.270(a) | Records incomplete |