FDA Inspection 981630 — Medtronic MiniMed, Inc.
The FDA completed an inspection of Medtronic MiniMed, Inc. on July 22, 2016 in Northridge, CA. 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
- July 22, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Northridge, CA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2993 | 21 CFR 812.140(b)(2) | Sponsor device disposition records inadequate |