FDA Inspection 1042385 — Amnii-X LLC
The FDA completed an inspection of Amnii-X LLC on February 20, 2018 in Plano, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 20, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Plano, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12411 | 21 CFR 1271.260(a) | Contamination, mix ups, improper release |
| 12414 | 21 CFR 1271.260(d) | Corrective actions |