FDA Inspection 634587 — Smiths Medical International Ltd.
The FDA completed an inspection of Smiths Medical International Ltd. on Dec 10, 2009 in Watford. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 8 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Dec 10, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Watford (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3291 | 21 CFR 820.100(b) | Procedures |
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |