FDA Inspection 1267148 — Horizon Scientific
The FDA completed an inspection of Horizon Scientific on Apr 18, 2025 in Summerville, SC. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Apr 18, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Summerville, SC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |