The FDA hit Veran Medical Technologies on handling of CAPAs and complaints as well as its documentation of acceptance activities.
The agency issued a Form 483 after a March 2018 inspection of the device manufacturer’s Saint Louis, Missouri facility. It found the facility did not properly document that the corrective actions it took did not adversely affect products and that it failed to adequately document that the corrective actions eliminated the problem.
The company also failed to follow its complaint review procedures and did not log at least five calls that should have been documented as potential complaints. Moreover, the company’s receiving inspection report for at least one lot did not have the required signatures of personnel responsible for the inspections.