FDA 483 - Benchmark Electronics, Inc. - August 26, 2020

An FDA inspection of Benchmark Electronics, Inc. in Nashua, NH, from August 24-26, 2020, revealed inadequate procedures for controlling environmental conditions. Specifically, the firm failed to adequately monitor humidity in operational and cleanroom areas and lacked documentation for non-conformances and product impact assessments related to these issues. This indicates a significant lapse in quality system controls for environmental monitoring.