FDA Inspection 1230830 — Tissue Transplant Technology, Ltd.
The FDA completed an inspection of Tissue Transplant Technology, Ltd. on May 3, 2024 in San Antonio, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 3, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- San Antonio, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12375 | 21 CFR 1271.210(a) | Use prior to verification |
| 12376 | 21 CFR 1271.210(b) | Use of non-sterile reagents |
| 12435 | 21 CFR 1271.270(a) | Records maintained concurrently |