FDA Inspection 709460 — Smiths Medical ASD, Inc.
The FDA completed an inspection of Smiths Medical ASD, Inc. on January 28, 2011 in Rockland, MA. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 28, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Rockland, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |