# FDA 483 - Orchid Orthopedic Solutions, LLC - June 18, 2025

Source: https://www.globalkeysolutions.net/records/483/orchid-orthopedic-solutions-llc/029ce56f-6c1a-44a7-bab8-23b696515f7f

> FDA 483 for Orchid Orthopedic Solutions, LLC on June 18, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Orchid Orthopedic Solutions, LLC
- Inspection Date: 2025-06-18
- Product Type: device
- Office Name: Detroit District Office
- Summary: An FDA inspection of Orchid Orthopedic Solutions, LLC in Holt, MI, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, specifically regarding risk determination for verification of effectiveness and proper CAPA follow-up. Additionally, nonconforming products were not adequately controlled, as several nonconforming material reports were closed without documenting root causes.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/orchid-orthopedic-solutions-llc/b48e33a3-e5ea-4e30-a020-386339b48c21

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