US FDA Flags Violations By Granules India, Supplier Of Paracetamol

India-West News Desk

WASHINGTON, DC – Granules India is digitizing its documentation and strengthening facility oversight to address compliance violations identified by the U.S. Food and Drug Administration (FDA) at its flagship Telangana manufacturing site.

The U.S. regulator previously flagged significant deficiencies at the plant, including inadequate contamination controls and poor maintenance of equipment. The FDA reported finding torn data records discarded in waste bags, highlighting failures in record-keeping procedures. While the warning did not mandate a production shutdown, it poses risks to the regulatory approval process for new products manufactured at that site.

To mitigate these regulatory risks, the company is transitioning its operational logbooks, batch manufacturing records, and badge cards to a digital format over the coming months, it said.

Granules India, a major global supplier of paracetamol and active pharmaceutical ingredients, relies heavily on the U.S. market for its revenue. The company currently operates ten manufacturing facilities across India, the United States, and Europe, and is preparing for potential follow-up inspections from the FDA, Reuters noted.