FDA Finds Multiple Faults at Second-Biggest Indian Drugmaker (1)

US 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 ...