Trigon International Falls Short on Acceptance Activities

Failure to establish adequate procedures for accepting finished devices and to control devices that don’t meet specifications were among the quality management lapses discovered during a Feb. 5-13 FDA inspection of Trigon International’s Aurora, Illinois facility.

Trigon, which manufactures military and emergency medical services equipment, failed to review acceptance activities for certain devices, and it failed to document equipment used to manufacture the devices and to follow its test procedures, the 483 said.

The FDA said the firm didn’t confirm device specifications and it failed to establish procedures for monitoring and controlling process parameters.