FDA 483 - GLPGCP Development (Asia) Pte. Ltd. - August 03, 2017

An FDA inspection of TELEMED, a manufacturer in Vilnius, Lithuania, from July 31 to August 3, 2017, identified 18 significant deficiencies. The observations highlight a widespread lack of established procedures across critical quality system areas, including complaint handling, design control, process control, and training. This indicates a fundamental breakdown in the firm's quality management system.