FDA Inspection 635947 — Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
The FDA completed an inspection of Arrow International, Inc. (Subsidiary of Teleflex, Inc.) on December 18, 2009 in Wyomissing, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 18, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: 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 |