Ethicon Handed Form 483 Over Complaint Handling
Surgical products maker Ethicon received a Form 483 for not properly evaluating and investigating complaints of device failures.
The Aug. 7, 2014, 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. Ethicon declined to comment on the form. Read it at www.fdanews.com/03-05-15-Ethicon.pdf.