FDA Inspection 626970 — Talisman Limited
The FDA completed an inspection of Talisman Limited on November 12, 2009 in Leesburg, VA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 12, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Leesburg, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 3291 | 21 CFR 820.100(b) | Procedures |
| 4189 | 21 CFR 820.198(a) | General |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |