FDA Inspection 1254544 — SigmaGraft Inc
The FDA completed an inspection of SigmaGraft Inc on Apr 25, 2025 in Fullerton, CA. 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
- Apr 25, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Fullerton, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12431 | 21 CFR 1271.265(e) | Procedures and release criteria |