FDA 483 - Domico Med-Device Llc - May 12, 2026
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During an inspection, Domico Med-Device Llc in Fenton, MI, was cited for significant deficiencies across its quality system. Observations included inadequate risk management documentation, insufficient equipment calibration justifications, and gaps in complaint handling procedures. The firm also lacked proper qualification for production infrastructure and had deficiencies in its corrective and preventive action system, indicating a broad need for quality system improvements.
ID · 6c630ba4-24b2-45bc-9fd8-fc0a93eda9d6