784525
Zimmer, Inc. — FEI 1000220733
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 21, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Warsaw, IN (United States)
Citations
| ID | CFR | Description |
|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |