FDA Inspection 1293384 — Hycor Biomedical LLC
The FDA completed an inspection of Hycor Biomedical LLC on November 26, 2025 in Garden Grove, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 26, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Garden Grove, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3171 | 21 CFR 820.198(b) | Rationale documented for no investigation |
| 3696 | 21 CFR 820.100(b) | Documentation |