FDA Inspection 711599 — Arrow International, Inc. (subsidiary of Teleflex, Inc.)
The FDA completed an inspection of Arrow International, Inc. (subsidiary of Teleflex, Inc.) on February 28, 2011 in Chelmsford, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 28, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Chelmsford, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |