FDA Inspection 1309458 — Hanuri Distribution Inc
The FDA completed an inspection of Hanuri Distribution Inc on March 26, 2026 in Chatsworth, CA. 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
- March 26, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Chatsworth, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23060 | ISO 13485:2016 Clause 5.6.1 | Management review procedures not documented |
| 23113 | ISO 13485:2016 Clause 7.3.5 | Records of design and development reviews not maintained |
| 23138 | ISO 13485:2016 Clause 7.4.1 | Procedures for purchasing process not documented |
| 23237 | ISO 13485:2016 Clause 8.3.1 | Procedure for nonconforming product not documented |