1037667
Avotec, Inc. — FEI 1000113348
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 12, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Stuart, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3409 | 21 CFR 820.200(d) | Service reports |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |