FDA Inspection 1278037 — OxiWear Inc.
The FDA completed an inspection of OxiWear Inc. on Jul 30, 2025 in Buffalo, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jul 30, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Buffalo, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2557 | 21 CFR 820.30(c) | Design input - documentation |