Ethicon Handed Form 483 Over Complaint Handling

April 17, 2015

Surgical products maker Ethicon received a Form 483 for not properly evaluating and investigating complaints of device failures.

The Aug. 7 form says the Johnson & Johnson subsidiary failed to determine if further investigation of the MDR-reportable complaints was necessary.

For example, a complaint report about the VICRYL plus Polyglactin 910 Suture cited breakage of sutures during a laparoscopic procedure. However, Ethicon failed to investigate the causes of the breakage, the form says. After another complaint about suture breakage with the same device during a fallopian tube procedure, the company again failed to investigate the cause of the event.

The FDA investigator also cited the company for not having adequate CAPA procedures.

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