# FDA 483 - Conformis, Inc. - September 20, 2019

Source: https://www.keypedia.com/records/483/conformis-inc/7529268a-48d0-4b0b-bc1b-765d620f2d02

> FDA 483 for Conformis, Inc. on September 20, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Conformis, Inc.
- Inspection Date: 2019-09-20
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: ConforMIS, Inc., a medical device manufacturer in Billerica, MA, was inspected regarding its quality system for the iTotal Hip Replacement System. The inspection revealed two significant issues related to design controls, specifically concerning inadequate documentation of design input requirements and design risk analysis results. These findings indicate deficiencies in the firm's adherence to medical device design control regulations.

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## Related Officers

- [Gregson A Joseph](https://www.keypedia.com/people/gregson-a-joseph/90bf8118-3f32-4f44-95c4-fcde1f741a18)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961