FDA 483 - Medi-Globe s.r.o. - May 24, 2018

An FDA inspection of Med-Globe s.r.o., a medical device manufacturer in Hranice, Czech Republic, identified three observations related to deficiencies in their quality system. The firm was cited for inadequate procedures concerning corrective and preventive actions, quality audits, and calibration. These findings indicate a need for the firm to strengthen its procedural controls to ensure compliance and product quality.