FDA Inspection 1084923 — Elucid Bioimaging Inc.
The FDA completed an inspection of Elucid Bioimaging Inc. on Apr 2, 2019 in Boston, MA. 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 2, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Boston, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |