FDA 483 - Ralco S.R.L. - July 21, 2022

Ralco S.R.L., a medical device manufacturer in Biascono, Italy, was cited for multiple deficiencies in its quality system during an FDA inspection. The observations highlight significant issues across various critical areas, including inadequate procedures for medical device reporting, complaint handling, nonconforming product disposition, design validation, CAPA documentation, equipment calibration, and personnel training. These findings indicate a systemic lack of adherence to regulatory requirements for quality management.