635947
Arrow International, Inc. (Subsidiary of Teleflex, Inc.) — FEI 3015859709
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 18, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Wyomissing, PA (United States)
Citations
| ID | CFR | Description |
|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3379 | 21 CFR 820.198(e)(5) | Nature and details of complaint |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |