483
Biomedics Systems IncBiomedics Systems Inc – FDA 483, Oct 4, 2019
Record Details
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.
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ID · ed626dd1-6dc0-40df-9cd9-f6b0ca0a0175
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