FDA Inspection 1291544 — Span Medical Products Canada d/b/a M.C. Healthcare Products
The FDA completed an inspection of Span Medical Products Canada d/b/a M.C. Healthcare Products on November 13, 2025 in Beamsville. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 13, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Beamsville (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |