FDA Inspection 1106961 — Life Recovery Systems HD, LLC
The FDA completed an inspection of Life Recovery Systems HD, LLC on October 21, 2019 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
- October 21, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Kinnelon, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |