# FDA 483 - Elucid Bioimaging Inc. - March 20, 2026

Source: https://www.keypedia.com/records/483/elucid-bioimaging-inc/c00b5f66-4d79-4925-8b26-c91765aba278

> FDA 483 for Elucid Bioimaging Inc. on March 20, 2026. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Elucid Bioimaging Inc.
- Inspection Date: 2026-03-20
- Product Type: device
- Office Name: New England District Office
- Summary: Elucid Bioimaging Inc., a medical device manufacturer in Boston, MA, was cited for deficiencies in its complaint handling procedures. The inspection revealed that the firm's procedures did not adequately define when complaints require corrective and preventive action, failed to conduct Medical Device Reporting determinations within required timeframes, and lacked provisions for documenting unique device identifiers (UDI) or Universal Product Codes (UPC) in complaint records.

## Related Officers

- [investigator](https://www.keypedia.com/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

Company: https://www.keypedia.com/companies/elucid-bioimaging-inc/bbfec801-76d5-4377-b57b-0045ffb4bd7f

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144