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Medical Devices / Inspections and Audits

Salem Devicemaker Hit for Out-Of-Calibration Equipment Procedures

Oct. 15, 2018

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.

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