# FDA 483 - HAPPE SPINE, LLC. - May 08, 2025

Source: https://www.globalkeysolutions.net/records/483/happe-spine-llc/af45bafd-51e3-4476-a46d-edb1c3ce13b8

> FDA 483 for HAPPE SPINE, LLC. on May 08, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: HAPPE SPINE, LLC.
- Inspection Date: 2025-05-08
- Product Type: device
- Office Name: Detroit District Office
- Summary: HAPPE SPINE, LLC. in Grand Rapids, MI, a manufacturer of medical devices, received two observations during an FDA inspection. The firm was cited for inadequately documented and ambiguous design input requirements for their HAPPE Spine Cervical Interbody device. Additionally, procedures for the acceptance of incoming products, specifically returned implants and instruments, were not adequately established or documented.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/felicia-e-armbrustmacher/83e0f3f7-2bfc-4250-8627-76685eee6b03)

Company: https://www.globalkeysolutions.net/companies/happe-spine-llc/4a76779f-822b-4b7e-9d5c-018cceef89b0

Office: https://www.globalkeysolutions.net/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03