FDA 483 - Anthea Pharma Private Limited - July 05, 2024

An FDA inspection of Anthea Pharma Private Limited in Patancheru Mandal Sangareddy, India, revealed significant deficiencies in laboratory controls, aseptic processing areas, and batch production and control records. The firm failed to establish scientifically sound test procedures, adequately monitor environmental conditions in aseptic areas, and properly investigate quality incidents and equipment breakdowns. These issues indicate a lack of robust quality management systems for drug manufacturing.