483
GLPGCP Development (Asia) Pte. Ltd.FDA 483 - GLPGCP Development (Asia) Pte. Ltd. - August 03, 2017
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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.
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ID · 50a62d71-bc66-4dc8-8812-78e3e9f52204