FDA 483 - Drucker Diagnostics - November 21, 2019

Brucker Diagnostics, a medical device manufacturer in Philipsburg, PA, was cited for a single observation regarding its complaint handling procedures. The firm failed to adequately review and evaluate complaints to determine the necessity of an investigation, specifically for Complaint #6360. Additionally, its procedure improperly exempted devices past warranty from full investigation, indicating a deficiency in the firm's quality system for complaint management.