1219313
Light Age, Inc. — FEI 2246844
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 29, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Somerset, NJ (United States)
Citations
| ID | CFR | Description |
|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3236 | 21 CFR 820.72(b) | Calibration procedures - content |
| 3237 | 21 CFR 820.72(b) | Remedial action |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |