The FDA hit The Morel Company of Batesville, Indiana with a Form 483, citing the devicemaker for incomplete device history records.
During an Oct. 30-Nov. 1, 2018 inspection, the agency investigator found that the firm failed to document adverse impact assessments in device history records following rework and reevaluation activities. This was a repeat observation from a previous agency inspection.
Three out of four records reviewed involving rework failed to include the assessments for the rework performed, the investigator said.
