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

Source: https://www.keypedia.com/records/483/conformis-inc/ba54dcbd-4718-4527-8284-11cee91e4c9e

> 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 Wilmington, MA, was inspected and cited for significant deficiencies in its quality system. Observations included inadequate process controls for sterilization, insufficient testing of incoming sterilization agents, non-compliance with clean room gowning procedures, and improper storage of labels leading to potential mix-ups. These issues indicate a lack of robust controls to ensure product quality and prevent contamination.

## Related Documents

- [WARNING_LETTER - 2019-11-15](https://www.keypedia.com/records/warning_letter/conformis-inc/0000ca0e-86a2-4c51-bc23-769aeb9a2f0b)
- [483 - 2026-01-13](https://www.keypedia.com/records/483/conformis-inc/4a31c65b-4c78-4f08-b960-e46f144b7acc)

## 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/670c416b-a103-4aff-965c-98384c5df4ed

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