FDA 483 - Dalton Medical Corp - September 15, 2022

Dalton Medical Corp, a specification developer and importer in Farmers Branch, TX, was cited with 10 observations during an FDA inspection from September 7-15, 2022. The inspection revealed significant deficiencies across its quality system, including a lack of established procedures for design control, complaint handling, supplier evaluation, MDR reporting, service reports, sampling plans, CAPA, quality audits, management review, and employee training. Several observations were repeats from a previous inspection, indicating persistent systemic issues.