Written complaints have historically been prioritized and more scrutinized by industry, viewing them as more official or easier to track. Oral complaints, often received through customer service calls or informal conversations, may have been documented inconsistently or given less weight in the investigation process.
Recent enforcement trends indicate FDA is focusing on oral complaint handling. FDA expects pharmaceutical companies to treat all complaints with equal diligence, regardless of the form in which they are received.
In this issue, we see a medical device company received a 483 for failing to document oral complaints procedures. The 483 reads:
Specifically, your firm’s SOP …,“Complaint Handling” procedure does not require oral complaints to be documented upon receipt and records of investigation to include a determination of whether the device failed to meet specifications, whether the device was being used for treatment or diagnosis, and the relationship, if any, of the device to the reported incident or adverse event. Also, the SOP states “should” rather than “shall.” Your firm has not documented any potential complaints since the previous inspection ending over seven years ago or ever.
In addition to the failing complaint handling system, the 483 also references mistakes in the firm’s SOP that states “should” rather than “shall.” Finally, the lack of documented complaints over the firm’s history brings great concern to FDA.
FDA’s position is clear: oral complaints are not informal communications to be disregarded—they are a critical part of the feedback loop for ensuring product quality and safety.
For information on a complaint handling system, including medical device complaints and investigations, see FDA Presentations Complaint Files and Complaints and Complaint Investigations.
