FDA Inspection 1259404 — MD Tox Laboratory
The FDA completed an inspection of MD Tox Laboratory on January 28, 2025 in Irvine, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 28, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12310 | 21 CFR 1271.160(a) | All core requirements covered in program |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |
| 12438 | 21 CFR 1271.270(b) | Management system re: core CGTPs |
| 12443 | 21 CFR 1271.270(d) | Retention time (10 year rules) |