FDA 483 - Bajaj Medical, LLC - October 01, 2019

Belo Medical, LLC in Chicago, IL was inspected by the FDA from September 24 to October 1, 2019. The inspection revealed that the firm failed to conduct required annual product reviews for its chlorhexidine gluconate 4.0% solution, despite having written procedures in place. This indicates a lapse in adherence to established quality system procedures for drug product oversight.