FDA Inspection 1187489 — HansBiomed USA, Inc.
The FDA completed an inspection of HansBiomed USA, Inc. on November 8, 2022 in Englewood Cliffs, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 8, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Englewood Cliffs, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |