FDA Faults Biomedix for Weak Process Validation
Biomedix WAI’s process validation procedures didn’t ensure that products would consistently meet specifications, an FDA inspection of the firm’s Bloomington, Indiana facility found.
The facility manufactures medical equipment for first responders, healthcare providers and the U.S. military.
The agency uncovered numerous validation failures for heat sealing and test equipment, according to the inspection report. The FDA investigator said the number of samples collected for each process qualification run was insufficient to meet the requirements of the validation sampling plan.