FDA Inspection 631769 — Bard Shannon Limited
The FDA completed an inspection of Bard Shannon Limited on Oct 9, 2009 in Rio Abajo HUMACAO, PR. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 5 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Oct 9, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: 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 |