Granules India Tightens Oversight After FDA Warning
Granules India is digitizing records and increasing oversight after a US FDA warning. The firm aims to cut regulatory risks through automated data collection.
The pharmaceutical manufacturer GRANULES INDIA LTD is intensifying its operational oversight and transitioning to digital record-keeping following a series of regulatory warnings from the United States Food and Drug Administration (FDA). The company, which is a major global supplier of paracetamol and active pharmaceutical ingredients, is addressing concerns regarding its largest manufacturing plant located in the state of Telangana, India.
Last year, the FDA identified several compliance failures at the Telangana facility, including inadequate cleaning procedures and poor contamination controls. Inspectors reportedly found significant quantities of shredded data records in waste disposal areas, raising questions about the site’s documentation integrity. While the facility continues to operate, the regulatory status could potentially impact the approval timeline for new products manufactured at the location.
