The FDA cited Philips Medical Systems for failure to investigate or properly review thousands of complaints in a Form 483 issued after a July/August 2017 inspection of the firm’s Cleveland facility.

Investigators found that out of 133,845 complaints from July 2016 to July 2017, more than 129,000 were closed based only on the assigned hazard/harm symptom code without further investigation. Nearly 1,800 complaints were not properly escalated and forwarded to the complaint-handling unit.

The Form 483 further faulted the company for its CAPA and complaint-handling procedures. The facility’s procedures for entering complaints do not describe how and when failure codes are entered, nor does the company have any procedure defining the codes. The firm only evaluated complaints and non-conformances for potential CAPAs when they meet an escalation threshold, which is not adequately defined or consistent.