FDA 483 - Biomedics Systems Inc - October 04, 2019

BIOMEDIC SYSTEMS INC., a medical gas transfiller in San Juan, PR, was cited for a significant deficiency in quality control during an FDA inspection. The firm failed to document required tests for empty cylinders, which are components for medical gas, before accepting them for use. This lapse resulted in the release of medical gas lots without proper verification that the components conformed to specifications.