FDA Inspection 1310622 — NEW LIFE DIAGNOSTICS, Inc.
The FDA completed an inspection of NEW LIFE DIAGNOSTICS, Inc. on April 2, 2026 in Carlsbad, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 2, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Carlsbad, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23182 | ISO 13485:2016 Clause 7.5.8 | No documented system to assign unique device identification (UDI) |
| 23260 | ISO 13485:2016 Clause 8.5.3 | Preventive action not determined |