The FDA said it could withhold approval of new products from Jubilant HollisterStier LLC, a facility located at Spokane, Washington, until the company takes action to comply with the regulator's good manufacturing practices, Jubliant Life Sciences said.
Jubilant HollisterStier will respond to the warning on or before December 12 and will take corrective actions to ensure compliance with the FDA, it added.
The facility accounted for 7 per cent of Jubilant Life Science's consolidated sales in the six months ended September.
Shares of Jubilant Life Sciences plunged 10 percent after the announcement, their steepest one-day fall in nearly six months, while the main Mumbai market was up 1.6 percent.
"We expect that the on-going manufacturing, distribution and sale of products from this facility will not be impacted as the WL (warning letter) will affect new approvals only," the company said in a statement.
Indian medicine makers, which produce nearly 40 percent of generic and over-the-counter drugs for the United States, have recently been battered by a rash of regulatory actions, including a record fine for Ranbaxy Laboratories Ltd and what amounts to a ban by the FDA on a second plant for Wockhardt Ltd.
Jubilant Life Sciences, which makes generics and provides contract manufacturing services, has 10 facilities in India, the United States and Canada.