FDA Inspection 1277105 — Telix IsoTherapeutics Group, Inc.
The FDA completed an inspection of Telix IsoTherapeutics Group, Inc. on July 31, 2025 in Angleton, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 31, 2025
- Fiscal Year
- 2025
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Angleton, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |