# FDA 483 - Orchid Orthopedic Solutions Alabama LLC - June 15, 2023

Source: https://www.keypedia.com/records/483/orchid-orthopedic-solutions-alabama-llc/0ee7fb13-ed08-45b0-b707-9b23d76fe415

> FDA 483 for Orchid Orthopedic Solutions Alabama LLC on June 15, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Orchid Orthopedic Solutions Alabama LLC
- Inspection Date: 2023-06-15
- Product Type: device
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Orchid Orthopedic Solutions Alabama LLC, a contract manufacturer of orthopedic solutions, revealed significant deficiencies in their quality system. Observations included inadequate procedures for handling nonconforming product rework and finished device acceptance, as well as an inadequately established and maintained organizational structure, particularly concerning quality management personnel roles and responsibilities.

## Related Officers

- [Jamie P. Webb](https://www.keypedia.com/people/jamie-p-webb/9e052469-54f7-4d56-b977-27babbdac09b)
- [investigator](https://www.keypedia.com/people/nikki-s-bryant/fe859d4f-23a6-4bc9-94c6-5b3c3fe8d99a)

Company: https://www.keypedia.com/companies/orchid-orthopedic-solutions-alabama-llc/ca4beab9-b803-4b3f-b4dc-99dd9fad28e7

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea