872544
Laser Engineering, Inc. — FEI 3000204219
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 4, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Nashville, TN (United States)
Citations
| ID | CFR | Description |
|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3239 | 21 CFR 820.72(b) | Remedial action - documentation |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |
| 5005 | 21 CFR 1002.11 | Failure to submit |
| 5144 | 21 CFR 1040.10(f)(2)(i) | Safety interlock not provided |
| 5197 | 21 CFR 1040.10(h)(1)(i) | User information, adequate instructions |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |