FDA 483 - SOPRO - July 21, 2022

An FDA inspection of SOPRO, a medical device manufacturer in La Ciotat cedex, France, revealed three significant observations. The firm failed to adequately establish procedures for complaint handling, lacked evidence of shipping validation for its S640 and Symbioz Flow Laparoscopic Insufflators, and utilized sampling plans not based on valid statistical rationale. These findings indicate deficiencies in the firm's quality system.