FDA 483 - CoreRX Inc. - June 14, 2019

CoreRx, Inc. in Clearwater, FL, was inspected by the FDA, revealing several deficiencies in quality control, facility maintenance, and documentation practices. Observations included unqualified test methods, uncalibrated balances, poor cleanroom drainage, inadequate cleaning records, and insufficient temperature and humidity control in the warehouse. Additionally, procedures for receiving temperature-sensitive materials were found to be inadequate.