FDA Inspection 640302 — Arrow International, Inc. (subsidiary of Teleflex, Inc.)
The FDA completed an inspection of Arrow International, Inc. (subsidiary of Teleflex, Inc.) on February 25, 2010 in Chelmsford, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 25, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Chelmsford, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3167 | 21 CFR 820.198(a) | Complete files maintained |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 733 | 21 CFR 803.50(b)(1) | Reporting Information Reasonably Known |
| 745 | 21 CFR 803.52(b)(2) | Death |
| 748 | 21 CFR 803.52(b)(2)(iii) | Injury or Illness Requiring Intervention |
| 812 | 21 CFR 803.56 | Submission of Supplement to Individual Report Within One Month |