FDA Inspection 1266729 — Microvascular Tissue, Inc
The FDA completed an inspection of Microvascular Tissue, Inc on Apr 8, 2025 in San Diego, CA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 8, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4382 | 21 CFR 211.198(b)(2) | Written record of complaint to include findings, follow-up |