Water Purification Company Warned on CAPAs, Investigations

MarCor Purification, a maker of water purification systems for the life sciences, has been warned by the FDA over CAPAs, investigations and complaint handling.

The Minnesota company failed to investigate several complaints, including one for a device with a defective heating element, where one of the coils exploded. “To date there has been no investigation to determine why a coil exploded,” the April 17 warning letter says.

Meanwhile, MarCor had not investigated a complaint of a drive motor sparking and burning or one of a flow meter leaking water.

Another citation notes that MarCor failed to document a corrective action to redesign a pump head assembly after multiple complaints of the pump smoking or catching fire. The company also lacked documentation for corrective and preventive actions for multiple design changes to correct a chemical pump intake that was not suctioning the correct amount of fluid.

The FDA went on to rap MarCor for failing to submit written reports on corrections and removals. For example, the company replaced the end cap on a pump following complaints that the pump caused smoke or fire, but did not submit a written report to the agency. It also failed to submit a report on a June 2013 decision to upgrade all Millenium HX devices in the field after complaints of water leaks and water issues with an old valve. And MarCor failed to notify the FDA in writing when it changed suppliers in March 2013.

The letter, posted recently online, says the company’s work instruction for complaint handling does not ensure that complaints are processed in a uniform and timely manner. It notes, for instance, that MarCor did not immediately enter into its complaint system a call log for a call stating that a boost pump had died. This was not entered until the customer called back and spoke with a different technician, the warning letter says. MarCor also failed to enter a May 2012 complaint about a solenoid that was not plugged back in and some loose wires until Jan. 15, 2013.

MarCor’s complaint handling work instruction further failed to ensure that complaints are evaluated for reportability, the letter says. One complaint involving a dialysis technician who received an electric shock due to a leak in a machine was initially deemed not reportable. But a reevaluation during the Jan. 29 to Feb. 18 inspection led to an MDR submission.

Another complaint involving a pump “burning up” was not evaluated for MDR reportability until the inspection, when it resulted in an MDR submission, the letter adds.

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