583462
Alphatec Spine, Inc. — FEI 2027467
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 18, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Carlsbad, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3250 | 21 CFR 820.72(b)(2) | Calibration documentation |
| 3687 | 21 CFR 820.100(a)(1) | Analysis of data sources |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 3839 | 21 CFR 820.70(a)(4) | Approval of process equipment |
| 4193 | 21 CFR 806.10(b) | Time to report - 10 days |
| 538 | 21 CFR 820.70(a) | Process control procedures |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |