FDA 483 - Frantz Medical Development Ltd - September 24, 2018

Frantz Medical Development Ltd, a medical device manufacturer in Mentor, OH, was cited with five observations during an FDA inspection. The observations primarily concern inadequately established procedures across several critical quality system areas, including CAPA, complaint handling, non-conforming product control, supplier management, and process validation. The firm's quality system appears to lack robust processes for data analysis, risk management integration, and clear operational definitions.