FDA 483 - Maiva Pharma Private Limited - August 02, 2019

Global Pharmatech Private Limited in Hosur, India, was inspected by the FDA from July 24 to August 2, 2019, resulting in two observations. The firm failed to thoroughly investigate the root cause of particulate matter found in a distributed injection batch. Additionally, procedures to prevent microbiological contamination were not adequately established, specifically regarding the validation and tracking of sterilization cycles for sterile goggles used in aseptic areas.