FDA 483 - Solomon Park Research Laboratories - January 08, 2026

Solomon Park Research Laboratories, Inc. in Burien, WA, received a Form 483 with three observations during an FDA inspection. The firm was cited for failing to establish written procedures for Medical Device Reporting (MDR) and for the disposition of nonconforming products. Additionally, the inspection revealed that the firm's medical devices did not bear unique device identifiers (UDI) as required by federal regulations.