FDA Inspection 952020 — Texas Children's Hospital - West Campus
The FDA completed an inspection of Texas Children's Hospital - West Campus on Sep 30, 2015 in Houston, 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 30, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 159 | 21 CFR 606.160(a)(1) | Legibility and indelibility |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 98 | 21 CFR 606.100(c) | Thorough investigations |