FDA 483 - GSB LLC - February 28, 2019

GSB, LLC, a contract manufacturer in Nashville, TN, was cited with 10 observations during an FDA inspection. The observations primarily concern inadequate validation of software and processes, insufficient equipment qualification and calibration procedures, and deficiencies in quality system procedures for document control, nonconforming product, complaint handling, and internal audits. The findings indicate significant gaps in the firm's quality management system.