FDA 483 - Philips Medical Systems (Cleveland) Inc - August 18, 2017

This FDA Form 483 details nine observations from an inspection, primarily concerning the facility's quality system and manufacturing processes, particularly in complaint handling, corrective and preventive actions (CAPA), and supplier controls.

**Observation 1** highlights inadequate investigation of complaints. Out of 133,845 complaints from July 2016-July 2017, 97% (129,736) were closed based only on symptom code without further investigation. 3,623 complaints with low HHM severity (level 4) had high RMM severity (potential serious injury/death), with 1,792 of these not escalated per procedure. Examples include issues with SPECT imaging system tables (e.g., "table continued to move," "table is stuck," "emergency stop switch 'pinged off'"), with 1,246 table-related complaints closed without further evaluation. Incomplete investigations were also noted for escalated complaints, such as a recurring reconstruction failure on an Ingenuity TF PET/CT system (22 similar complaints since 2013) that was not forwarded to CAPA or assessed by the Product Safety Committee.

**Observation 2** states that procedures for receiving, reviewing, and evaluating complaints are not adequately established. Failure codes are not consistently entered for all complaints (97% lacked them), and existing codes like "(b)(4)" lack sufficient detail