FDA Inspection 1048948 — Tissue Transplant Technology, Ltd.
The FDA completed an inspection of Tissue Transplant Technology, Ltd. on April 19, 2018 in San Antonio, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 19, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- San Antonio, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12325 | 21 CFR 1271.160(b)(6) | Deviations--evaluation, cause, corrective action |
| 12395 | 21 CFR 1271.225 | Verification/validation |
| 12403 | 21 CFR 1271.230(c) | Change activities documented |