FDA 483 - SENO MEDICAL INSTRUMENTS, INC. - March 10, 2022

SENO MEDICAL INSTRUMENTS, INC. in San Antonio, TX, was cited for multiple deficiencies during an FDA inspection. The observations primarily concern inadequate design controls, including issues with design output review, verification, and validation procedures. Additionally, the firm failed to validate critical manufacturing processes and equipment, maintain complete device history records, and establish adequate statistical techniques for process control.