FDA Inspection 902857 — ZIMMER ORTHOPEDIC MFG LTD
The FDA completed an inspection of ZIMMER ORTHOPEDIC MFG LTD on October 16, 2014 in Shannon. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 16, 2014
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Shannon (Ireland)
Citations
| ID | CFR | Description |
|---|---|---|
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |