# FDA 483 - Figure 8 Surgical, Inc. - December 18, 2019

Source: https://www.keypedia.com/records/483/figure-8-surgical-inc/2a45b681-7bfe-45fc-b240-b060030e4c12

> FDA 483 for Figure 8 Surgical, Inc. on December 18, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Figure 8 Surgical, Inc.
- Inspection Date: 2019-12-18
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Figure 8 Surgical, Inc. in Morgantown, WV, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm was cited for inadequate procedures related to complaint handling, product identification throughout all stages, and design validation. These issues indicate a need for improved procedural controls to ensure compliance with regulatory requirements.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/dennis-r-hock/f13e2db1-b808-466d-a974-e5af2d5dfdb0)

Company: https://www.keypedia.com/companies/figure-8-surgical-inc/c854fb66-55d6-4b32-ba31-7f283710270f

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8