483
SOPROFDA 483 - SOPRO - July 21, 2022
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
Open in Dashboard
ID · 1c574ef9-d4e9-4e58-afc7-bb58c66c31b0