FDA 483 - Sterilization Services Of Virginia - June 29, 2022

Sterilization Services Of Virginia, a contract sterilization facility in Richmond, VA, received a Form FDA 483 with two observations. The firm was cited for failing to adequately document software validation activities for an Excel-based spreadsheet used for quality system documentation. Additionally, procedures for controlling non-conforming product were not adequately established or implemented, resulting in numerous non-conformance reports with insufficient investigations and verifications.