AMN /
US Food and Drug Administration has banned imports from another India-based drug manufacturing plant over quality control concerns. The FDA’s import alert on Mumbai-based Polydrug Laboratories Pvt Ltd’s Ambernath manufacturing plant comes two months after Canada banned the same site, citing data integrity issues.
Europe also barred imports from the plant in early June citing critical deficiencies, including that staff deliberately did not record customer complaints. Polydrug makes drugs to treat hypertension, fungal diseases, and muscle relaxants, and exports them to more than 70 countries across Europe, North America and Asia, according to its website. The company did not immediately respond to a request seeking comment , after the FDA posted a notice of the ban on its website.