884721
Zimmer Manufacturing B.V. — FEI 1000132037
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 11, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mercedita, PR (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3138 | 21 CFR 820.130 | Packaging |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |