FDA Inspection 1302344 — Life Recovery Systems HD, LLC
The FDA completed an inspection of Life Recovery Systems HD, LLC on Feb 5, 2026 in Kinnelon, NJ. 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
- Feb 5, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Kinnelon, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23151 | ISO 13485:2016 Clause 7.4.3 | Purchased product verification activities are inadequate |