FDA Inspection 1023269 — Medtronic Puerto Rico Operations Co.
The FDA completed an inspection of Medtronic Puerto Rico Operations Co. on Aug 29, 2017 in Juncos, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 29, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Juncos, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |