FDA 483 - Signal Medical Corporation - April 10, 2023

Signal Medical Corporation in Marysville, MI, a medical device establishment, was cited for multiple quality system deficiencies during an FDA inspection. Observations included inadequate statistical techniques for process control, design history files not conforming to current design control procedures and 21 CFR 820, and failures in monitoring critical suppliers. Additionally, the firm lacked adequate training procedures, specifically for key personnel involved in device recalls.