FDA 483 - Sterilization Services Of Virginia - May 06, 2015

An FDA inspection of Sterilization Services Of Virginia, Inc. in Richmond, VA, a contract sterilizer, revealed significant deficiencies in its quality system. The firm failed to adequately establish and implement corrective and preventive action procedures, leading to inadequate investigations and verifications for multiple non-conformances. Additionally, a conflict of interest was identified where the Quality Assurance Supervisor, responsible for daily quality activities, performs all internal audits.