FDA 483 - Production Systems Inc - March 12, 2026

An FDA inspection of Production Systems, Inc. in Shoreview, MN, a manufacturer of cables and adaptors for electrosurgical devices, revealed a significant deficiency in their quality system. The firm failed to adequately document its risk management processes for product realization. This included a lack of documented risk management plans, hazard identification records, risk evaluation records, risk control measures, residual risk justifications, and risk management reports.