Drucker DiagnosticsNovember 21, 2019

FDA 483 - Drucker Diagnostics - November 21, 2019

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Record Details

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.

Company: Drucker Diagnostics
Inspection Date: November 21, 2019
Product Type: Device
Office: Philadelphia District Office
Person: Katelyn A. Staub-Zamperini

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ID · ecd49e34-3977-4911-873d-f5febdd66443