FDA 483 - PerkinElmer Medical Imaging - August 08, 2019

An FDA inspection of PerkinElmer Medical Imaging in Santa Clara, CA, from August 5-8, 2019, revealed two significant observations. The firm was cited for failing to include required investigation details or reasons for not investigating in complaint records. Additionally, the inspection found that document control procedures were not adequately established and maintained, specifically concerning equipment found to be out of calibration but still available for use.