FDA 483 - Pioneer Surgical Technology Inc. - June 14, 2024

Pioneer Surgical Technology Inc. in Marquette, MI, a medical device manufacturer, was cited with two observations on a Form FDA-483. The inspection revealed significant deficiencies in the firm's corrective and preventive action (CAPA) procedures, including issues with risk identification, timeliness, root cause analysis, and effectiveness verification. Additionally, the firm's training procedures were found to be inadequate, failing to ensure employee training requirements are met.