FDA Inspection 1260086 — Parkview Health Laboratories
The FDA completed an inspection of Parkview Health Laboratories on January 30, 2025 in Fort Wayne, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 30, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Fort Wayne, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 150 | 21 CFR 606.151(e) | Procedures to maintain records of emergency transfusions |