# FDA 483 - Conformis Inc. - January 13, 2026

Source: https://www.keypedia.com/records/483/conformis-inc/4a31c65b-4c78-4f08-b960-e46f144b7acc

> FDA 483 for Conformis Inc. on January 13, 2026. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Conformis Inc.
- Inspection Date: 2026-01-13
- Product Type: device
- Office Name: New England District Office
- Summary: An FDA inspection of Conformis Inc. in Wilmington, MA, revealed inadequate procedures for receiving, reviewing, and evaluating complaints. Specifically, a significant number of complaint files lacked the required Unique Device Identifier (UDI) or Universal Product Code (UPC) documentation. This indicates a notable deficiency in the firm's complaint handling system for its medical devices.

## Related Documents

- [483 - 2019-09-20](https://www.keypedia.com/records/483/conformis-inc/ba54dcbd-4718-4527-8284-11cee91e4c9e)
- [WARNING_LETTER - 2019-11-15](https://www.keypedia.com/records/warning_letter/conformis-inc/0000ca0e-86a2-4c51-bc23-769aeb9a2f0b)

## Related Officers

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

Company: https://www.keypedia.com/companies/conformis-inc/670c416b-a103-4aff-965c-98384c5df4ed

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