FDA Inspection 1258966 — Echopixel, Inc.
The FDA completed an inspection of Echopixel, Inc. on Jan 15, 2025 in San Jose, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 15, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- San Jose, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3168 | 21 CFR 820.198(a) | Complaints |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |