FDA Finds Multiple Faults at Second-Biggest Indian Drugmaker
- Indian firms in spotlight as FDA races through Covid backlog
- Aurobindo Pharma is second-largest Indian drugmaker by revenue
Employees work at an Aurobindo Pharma Ltd. production facility in Jadcherla, India.
Photographer: Prashanth VishwanathanUS Food and Drug Administration officials found multiple faults at a plant run by one of India’s biggest drugmakers as the watchdog continues to unearth wide-ranging lapses across the country’s factories while working through a pandemic-era inspection backlog.
Auditors uncovered “deficient” manufacturing equipment cleaning and storage controls during a visit last month to an Aurobindo Pharma Ltd. facility in Anakapalli, eastern India, according to a FDA report obtained by Bloomberg News through a Freedom of Information Act request. Sampling tools weren’t cleaned and maintained to prevent contamination at the plant, which produces certain active pharmaceutical ingredients — the raw materials core to making drugs.