483
Orchid Orthopedic Solutions Alabama LLCOrchid Orthopedic Solutions Alabama LLC – FDA 483, Jun 15, 2023
Record Details
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.
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