FDA 483 - Sea-Long Medical Systems, LLC - November 05, 2024

An FDA inspection of Sea-Long Medical Systems, LLC in Waxahachie, TX, revealed 11 significant quality system deficiencies related to the manufacturing of hyperbaric chamber devices. The firm failed to establish or adequately implement procedures for critical areas such as process validation, complaint handling, CAPA, finished device acceptance, supplier control, UDI labeling, incoming material acceptance, training, design change, device history records, and quality audits. Many of these issues were repeat observations from a previous inspection, indicating a systemic lack of compliance.