FDA Inspection
Elucid Bioimaging Inc.Elucid Bioimaging Inc. – FDA Inspection, Apr 2, 2019
Record Details
This FDA Inspection record concerns Elucid Bioimaging Inc., with an inspection on April 2, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ec580ff8-78d7-4414-8d21-2ab554440ff3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1084923
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 820.30(f)Design verification - documentation
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Other FDA inspections of Elucid Bioimaging Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 20, 2026 | NAI | New England District Office | Postmarket Assurance: Medical Devices |
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