FDA Inspection 1075469 — Texas Donor Network
The FDA completed an inspection of Texas Donor Network on Dec 14, 2018 in Harlingen, 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 14, 2018
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Harlingen, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12258 | 21 CFR 1271.60(c)(3) | Statement of restrictions |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |