FDA 483 - Sea-Long Medical Systems, LLC - September 08, 2022

Sea-Long Medical Systems, LLC, a medical device manufacturer in Waxahachie, TX, was inspected by the FDA from August 22 to September 8, 2022. The inspection revealed significant deficiencies across multiple quality system areas, primarily concerning the lack of established and adequately implemented procedures for complaint handling, process validation, design change, CAPA, non-conforming materials, finished device acceptance, incoming product acceptance, device master records, device history records, quality audits, and management review. These findings indicate a systemic failure to maintain a compliant quality system for their hyperbaric chamber devices, hoods, and neck seals.