Granules India, one of the world's largest manufacturers of paracetamol and active pharmaceutical ingredients, is responding to a warning from the U.S. Food and Drug Administration (FDA) by enhancing oversight at its manufacturing facilities. The FDA highlighted violations at the company's largest plant in Telangana, India, including inadequate record-keeping and contamination control practices. Notably, the FDA found torn data records in plastic waste bags, indicating serious lapses in compliance. While production continues, these violations could delay FDA approval for new products from the site. To address these issues, Granules plans to digitize its operations logbooks, batch manufacturing records, and employee badge cards over the coming months. Priyanka Chigurupati, the company's executive director, emphasized the importance of adapting to these challenges by implementing automation and tightening controls across its facilities. The company is also increasing the frequency of 'gemba walks,' where managers observe manufacturing practices to identify and resolve bottlenecks, thereby enhancing product quality.