779697
InBios International, Inc. — FEI 3002606748
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- May 4, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Seattle, WA (United States)
Citations
| ID | CFR | Description |
|---|
| 14715 | 21 CFR 820.30(d) | Design output - Lack of or inadequate procedures |
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3108 | 21 CFR 820.70(e) | Contamination control, Lack of or inadequate procedures |
| 3115 | 21 CFR 820.70(h) | Use and removal, Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 3841 | 21 CFR 820.90(b)(2) | Product rework adverse effects {see also 820.184} |