HeartWare International disclosed a month ago that it had received a warning letter from the FDA. Now more details are out from the FDA over the alleged lack of corrective action procedures and other issues that sparked the FDA warning.The FDA warning letter came after the agency's January inspection of the company's operations, development and manufacturing facility in Miami Lakes, FL.The actual text of the warning letter, recently released, shows FDA concern over how Framingham, MA-based HeartWare failed to verify or validate the effectiveness of corrective actions responding to 27 complaints between February 2010 and November 2013, including reports of two deaths and four serious injuries, related to HeartWare's Ventricular Assist Device (HVAD) system.The FDA also noted other instances of failure to establish and maintain procedures for implementing corrective and preventive action (CAPA).The Miami Lakes facility manufactures HeartWare's HVAD system, which comprises an implanted pump connected to an external controller.While HeartWare had addressed the issues noted on an FDA Form 483, those responses were not deemed sufficient to allay the inspector's concerns in four areas, according to the FDA.The FDA also found the firm's procedure for validating the device design does not require design validation of device labeling, i.e. the Patient Manual, to ensure that it is properly understood by patients and caregivers.FDA said, "(Y)our firm provided documentation of updated procedures and training modules. However, your firm did not indicate what retrospective activities will be conducted to ensure that design validation for the HVAD system was adequately handled."Further, HeartWare's own CAPA procedures updated in response to premature battery failure issues related to at least 238 complaints and Medical Device Reporting (MDR) events were not adequately implemented. Additionally, HeartWare "did not complete rework of controller inventory with updated ESD shield design or complete any type of field action after release of the updated ESD shield design." The firm also "initiated field actions in response to complaints regarding loose driveline connectors. However, corrective actions were not effective in that driveline connectors again came loose."Additional issues identified included changes to procedures and training of personnel. "However, your firm did not indicate what actions will be taken to assess the effectiveness of the corrections and whether retrospective assessments will be performed to determine if the root causes were adequately addressed by the corrections."Also, although a new software tester installed as part of a corrective action to address premature battery failure issues related to 238 complaints and 119 MDR events was implemented on July 23, 2013, that software was not validated until September.HeartWare was given the customary 15 days to address these issues.

The warning letter comes only months after the FDA issued a Class I designation over a voluntary recall involving the HeartWare Ventricular Assist System. Regulators think there is danger of serious injury or death because of a faulty driveline connector that could cause the heart pump to temporarily stop.

Stephen Levy is a contributor to Qmed and MPMN.

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