Lumitex Medical Devices Inc – FDA 483, May 1, 2026
Lumitex Medical Devices Inc, a manufacturer in Brecksville, OH, received two observations during an FDA inspection. The firm failed to adequately document reasons for not initiating corrective actions for customer complaints related to their Bilisoft 2.0 Phototherapy System. Additionally, the company lacked proper controls, including a quality agreement, for an outsourced critical component of the device, indicating deficiencies in their quality system regarding complaint handling and supplier management.
ID · 1c98ded3-ac37-4f93-a0e1-8303e7868bbc
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