FDA 483 - Mirodx - September 26, 2025

Mirodx, a medical device manufacturer in Dallas, TX, was issued a Form 483 with three observations following an FDA inspection. The firm failed to conduct adequate risk analyses for its Class II VERIS CareKits and exhibited deficiencies in establishing and maintaining records for acceptable suppliers, including missing onsite audits. Additionally, internal quality audits were not conducted by individuals independent of the areas being audited, indicating significant quality system concerns.