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Violation Tracker Individual Record

Company: Pentax Medical Company
Penalty: $43,000,000
Year: 2020
Date: April 7, 2020
Offense Group: safety-related offenses
Primary Offense: drug or medical equipment safety violation
Violation Description: Pentax Medical Company agreed to pay $43 million to resolve criminal charges as part of a deferred prosecution agreement based on the company's shipment of four types of endoscopes for 18 months without FDA-cleared instructions for use and the company's failure to file timely reports of two infections associated with its endoscopes.
Level of Government: federal
Action Type: agency action
Agency: Justice Department Civil Division
Civil or Criminal Case: criminal
Prosecution Agreement: deferred prosecution agreement
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Current parent company note: Parent-subsidiary relationship is current as of the most recent revision listed in the Update Log.