FDA Inspection 1318872 — Light Age, Inc.
The FDA completed an inspection of Light Age, Inc. on May 15, 2026 in Somerset, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 15, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Somerset, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23038 | ISO 13485:2016 Clause 4.2.4 | Lack of document control |
| 23157 | ISO 13485:2016 Clause 7.5.1 | Medical device or batch records not adequate |
| 23200 | ISO 13485:2016 Clause 7.6 | Equipment calibration or verification not performed |
| 23219 | ISO 13485:2016 Clause 8.2.2 | Complaint handling records not maintained |
| 23220 | ISO 13485:2016 Clause 8.2.4 | Internal audits not conducted to ensure QMS meets requirements and is effective |
| 23237 | ISO 13485:2016 Clause 8.3.1 | Procedure for nonconforming product not documented |
| 23243 | ISO 13485:2016 Clause 8.3.3 | Appropriate action not taken for nonconforming product after delivery or use |
| 23253 | ISO 13485:2016 Clause 8.4 | Records of data analysis results not maintained |
| 23262 | ISO 13485:2016 Clause 8.5.3 | Preventive action records not maintained |