FDA Inspection 645528 — Alphatec Spine, Inc.
The FDA completed an inspection of Alphatec Spine, Inc. on February 11, 2010 in Carlsbad, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 11, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Carlsbad, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2601 | 21 CFR 820.30(d) | Essential design outputs |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 538 | 21 CFR 820.70(a) | Process control procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |
| 778 | 21 CFR 803.52(f)(1) | Type of Reportable Event |