FDA Inspection 1311494 — Amnion LLC
The FDA completed an inspection of Amnion LLC on April 8, 2026 in Sterling, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 8, 2026
- Fiscal Year
- 2026
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Sterling, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12323 | 21 CFR 1271.160(b)(5) | Monitoring systems |
| 12354 | 21 CFR 1271.190(d)(2) | Documentation of activities |
| 12381 | 21 CFR 1271.210(d)(2) | Verification elements |
| 12435 | 21 CFR 1271.270(a) | Records maintained concurrently |