Inadequate CAPA procedures and failure to investigate failures of the CorTemp ingestible core body temperature sensor devices landed devicemaker HQ a Form 483 following a September 2017 FDA inspection of its Palmetto, Florida facility.

The FDA inspector noted that the firm failed to initiate corrective and preventive actions on at least four occasions for high numbers of nonconforming products.

Nonconforming products were not discussed in meetings and the facility had no records of an investigation of environmental control conditions that may have affected electrostatic discharge. Records didn’t indicate whether there was an investigation to determine if component suppliers made changes to the product or whether they failed to control their production processes.

At least six of 11 complaint records failed to document a complete investigation into the malfunctioning CoreTemp devices. In a few cases the investigation was limited to a review of the device history records, and a few potential causes for the failures were listed but apparently were not followed up. This was a repeat observation from a July 2012 inspection.