# FDA 483 - Conformis, Inc. - March 09, 2023

Source: https://www.globalkeysolutions.net/records/483/conformis-inc/93596f10-0732-423a-883c-86dd4c338fe5

> FDA 483 for Conformis, Inc. on March 09, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Conformis, Inc.
- Inspection Date: 2023-03-09
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Conformis, Inc. in Billerica, MA, a specification developer, received a Form FDA 483 with four observations highlighting significant deficiencies in their quality system. Issues included inadequate procedures for corrective and preventive actions, design input controls, and complaint handling, leading to unaddressed systemic problems and incomplete investigations. The firm also failed to ensure timely complaint closures and proper MDR filing.

## Related Documents

- [483 - 2018-09-07](https://www.globalkeysolutions.net/records/483/conformis-inc/c23d4393-b80f-42b2-b0e4-ce057d2e7844)
- [483 - 2018-09-07](https://www.globalkeysolutions.net/records/483/conformis-inc/0514b5ab-ceff-4ca9-85f9-03c06e4aad36)
- [483 - 2019-09-20](https://www.globalkeysolutions.net/records/483/conformis-inc/7529268a-48d0-4b0b-bc1b-765d620f2d02)

## Related Officers

- [Sunita Pandey](https://www.globalkeysolutions.net/people/sunita-pandey/008e5bb8-0eb3-45d8-8524-734ac0454250)

Company: https://www.globalkeysolutions.net/companies/conformis-inc/4d049221-15de-4b53-addf-68ea7fed8cbc

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7