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Medical Devices / Inspections and Audits

Indiana Devicemaker Nailed for Device History Records

March 20, 2019
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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.

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