The U.S. Food and Drug Administration issued a warning letter to Jubilant Life Sciences Ltd.'s manufacturing plant in India for not investigating drug quality and customer complaints.
In a March 6 letter, the U.S. regulator said the Jubilant's facility in Roorkee, in the state of Uttaranchal, did not test all batches of a product at its quality-control lab after one batch failed the quality test, something the company's management had been warned about previously.
The FDA also said the company did not thoroughly investigate customer complaints regarding damage to the coating of certain delayed-release tablets, which could affect dissolution.
The agency said it may withhold any pending approval applications or supplements from the company's facility until it corrects all violations.
In December 2018, the FDA recommended regulatory action after an inspection of the facility and said it may withhold any pending approval applications or supplements from Jubilant's Roorkee facility of solid dosage formulations.
India-based Jubilant manufactures and supplies active pharmaceutical ingredients and nutritional products, among others.