Granules Tightens Oversight After FDA Warning
Granules India Ltd is strengthening oversight at its manufacturing facilities and digitising key records after the U.S. Food and Drug Administration flagged compliance issues at its largest plant in Telangana. The regulator had pointed out lapses in record-keeping, equipment cleaning, and contamination controls, including the discovery of torn data records in waste bags. While the warning has not stopped production, it may delay approvals for new products from the affected site.
The company, a major global producer of paracetamol and active pharmaceutical ingredients, depends heavily on the U.S. market for revenue. In response to the observations, Granules is moving logbooks, batch records, and access systems online to reduce regulatory risks and improve traceability. Leadership expects a follow-up FDA inspection soon and is preparing accordingly.
As part of corrective measures, Granules has increased “gemba walks,” where managers closely monitor operations to detect issues early and halt processes if needed to protect product quality. The company also plans to invest in automation and tighter data controls across facilities, marking a shift toward stronger compliance practices and modernised manufacturing systems.
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