Salem Devicemaker Hit for Out-Of-Calibration Equipment Procedures

The FDA hit Coherent’s Salem, New Hampshire device manufacturing facility with a Form 483 for shortcomings in its evaluations of out-of-calibration equipment and corrective actions.

In an April inspection, the agency found that the firm received two certificates of calibration in October 2016 reporting that certain calibration instruments were out-of-tolerance, but it failed to document the out-of-calibration equipment as a nonconformance and to investigate the possible impacts on its products.

The facility also failed to thoroughly verify or validate the effectiveness of its procedures for corrective and preventive actions.