FDA Inspection 878310 — Smiths Medical ASD, Inc.
The FDA completed an inspection of Smiths Medical ASD, Inc. on Apr 23, 2014 in Saint Paul, MN. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 23, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Saint Paul, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 4193 | 21 CFR 806.10(b) | Time to report - 10 days |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |