FDA 483 - The Lebanon Corporation, Inc. - June 28, 2019

The Lebanon Corporation, Inc. in Lebanon, IN, received a Form FDA-483 following an inspection that identified significant deficiencies. The firm's risk analysis procedures were found inadequate, failing to update risk assessments with identified hazards and showing inconsistencies in severity and probability scores. Additionally, procedures for receiving, reviewing, and evaluating complaints were not adequately established, with no documentation of malfunction reportability assessments for reviewed complaints.