829344
Laser Engineering, Inc. — FEI 3000204219
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 17, 2013
- Fiscal Year
- 2013
- 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 |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3239 | 21 CFR 820.72(b) | Remedial action - documentation |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |
| 5143 | 21 CFR 1040.10(f)(1) | Protective housing |
| 5144 | 21 CFR 1040.10(f)(2)(i) | Safety interlock not provided |
| 5173 | 21 CFR 1040.10(g)(5)(i) | Aperture label - laser radiation |
| 5189 | 21 CFR 1040.10(g)(7)(v) | DIPH label wording - Class IV |
| 5202 | 21 CFR 1040.10(h)(1)(vi) | 50 mm classification warning |
| 5670 | 21 CFR 1040.10(h)(2)(ii) | Reproductions of warnings |
| 5802 | 21 CFR 1002.13 | Lack of required elements |