FDA Inspection 1282688 — Texas Children's Hospital North Austin
The FDA completed an inspection of Texas Children's Hospital North Austin on Sep 17, 2025 in Austin, TX. 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
- Sep 17, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Austin, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |