FDA Inspection 631769 — Bard Shannon Limited
The FDA completed an inspection of Bard Shannon Limited on October 9, 2009 in Rio Abajo HUMACAO, PR. 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
- October 9, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Rio Abajo HUMACAO, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3167 | 21 CFR 820.198(a) | Complete files maintained |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 4189 | 21 CFR 820.198(a) | General |