1006563
National Biological Corp — FEI 1521608
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 20, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Beachwood, OH (United States)
Citations
| ID | CFR | Description |
|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |