483
Orchid Orthopedic Solutions Alabama LLCFDA 483 - Orchid Orthopedic Solutions Alabama LLC - June 15, 2023
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
Open in Dashboard
ID · 0ee7fb13-ed08-45b0-b707-9b23d76fe415