FDA 483 - Linemaster Switch Corporation - February 15, 2023

Linemaster Switch Corporation in Woodstock, CT, a medical device manufacturer, was issued a Form FDA 483 following an inspection from February 7-15, 2023. The inspection revealed significant deficiencies in equipment validation, documentation of rework and reevaluation activities, and incomplete device history records. These observations indicate a lack of adequate quality system controls over critical manufacturing processes.