FDA 483 - Professional Contract Sterilization, Inc. - February 16, 2024

An FDA inspection of Professional Contract Sterilization, Inc. in Taunton, MA, revealed significant quality system deficiencies related to the contract sterilization of medical devices. Observations included insanitary facility conditions with water leaks and mold, cluttered laboratories, and inadequate environmental controls. The firm also failed to adequately validate bioburden testing, document in-process activities, ensure proper training for critical personnel, investigate quality data, and maintain equipment calibration.