FDA 483 - Caliber Imaging and Diagnostics, Inc. - October 10, 2019

An FDA inspection of Caliber Imaging and Diagnostics, Inc. in Rochester, NY, a medical device manufacturer, revealed multiple significant deficiencies in their quality system. The firm failed to adequately establish and follow procedures for corrective and preventive actions, control of nonconforming products, complaint handling, document control, and supplier evaluation. Additionally, records for electronic product radiation safety testing were not established, indicating a broad pattern of non-compliance with quality system regulations.