FDA Inspection 1219183 — Elite BioFusion LLC
The FDA completed an inspection of Elite BioFusion LLC on September 29, 2023 in Anaheim, CA. 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
- September 29, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Anaheim, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12312 | 21 CFR 1271.160(b)(2) | Procedures for complaints and other information |
| 12431 | 21 CFR 1271.265(e) | Procedures and release criteria |
| 12440 | 21 CFR 1271.270(b) | Prompt retrieval from multiple locations |