FDA Inspection 1294794 — Medtronic, Inc.
The FDA completed an inspection of Medtronic, Inc. on December 10, 2025 in Minneapolis, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 10, 2025
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Minneapolis, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |