It’s the Journey, Not Just the Destination: FDA Says Have a Procedure, Use the Procedure, or Go Back and Do It from the Beginning

The Food and Drug Administration recently posted a Warning Letter issued to a medical device manufacturer following a facility inspection citing a laundry list of alleged violations related to the company’s Corrective and Preventative Action (CAPA) procedures and Quality System Regulations (QSRs) processes.


FDA found fault with the manufacturer’s CAPA because it did not require validating and verifying the corrective and preventive action to ensure that the action is effective and does not adversely affect the finished product. FDA also cited the lack of documentation of verification and validation for a series of corrective action reports. The company’s addressing an influx of battery complaints by changing battery suppliers without processing the complaints through its CAPA system was also cited by the agency. Fixing the problem was not enough. Having a (flawed) CAPA process was not enough. Implementing the CAPA was required.

Among other objections, FDA identified numerous failures to comply with a variety of QSR requirements, including the failure to have procedures for design change approval or for validating device design failure. It appears that the company attempted to address these and other FDA objections, in some cases, by creating the missing procedures and applying them retrospectively to the specific instances FDA identified as examples of the failure. FDA was consistent in finding these responses inadequate because they did not include a retrospective review of, e.g., other design changes.

AGG Observations

  • Having a CAPA is not enough. And figuring out a solution to a problem is not enough. Complaints need to be processed using the CAPA to be in compliance with medical device regulations. Companies need to keep in mind that they not only need to have these processes in place on paper, but need to use them consistently. 
  • As one would expect, if FDA believes a company failed to have a CAPA or QSR process in place, it will require that the process be developed and implemented, and that the examples FDA identified of changes or events that needed to be processed through the missing or inadequate process be revisited. FDA may also, however, require that the company do a retrospective review of, e.g., all device design changes to ensure they were appropriately validated. A retrospective analysis can be very time consuming and expensive for the company depending on the number of device changes that have occurred.