Covidien Gets Warning Letter After No CAPA Investigations Found
Covidien’s January recall of a surgical staple product hasn’t ended the company’s troubles, as an FDA warning letter questioning Covidien’s handling of safety concerns makes clear.
The June 14 letter from the FDA’s New England District Office follows a Jan. 13, 2011,– Feb. 9 inspection of Covidien’s New Haven, Conn., plant.
Covidien recalled single-use units of Duet TRS, a tissue reinforcement product used in thoracic surgery, following the deaths of three patients. The product includes a filler, as well as staples that can be used in tissues during surgical procedures. Duet TRS “has the potential to injure adjacent anatomical structures within the thorax” and cause life-threatening complications, Covidien said at the time.
But, that recall and a related investigation came years after Covidien first knew there might be a problem with Duet TRS, the FDA said. “Despite receiving numerous complaint, adverse event and serious adverse event information since May of 2009 regarding use of the Duet TRS, a [corrective and preventive action] investigation was not initiated until Jan. 19, 2012, and after the FDA inspection team requested to review the CAPA file related to these complaints and adverse events,” the warning letter states.
In response to this observation on the Form 483, the company said it had not believed CAPA investigations were required for the situation, the letter adds. The FDA deemed the response inadequate because the company did not describe or provide proof of implementation of a retrospective corrective action plan.
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