Mumbai-based Glenmark Pharmaceuticals says it received seven observations during an FDA inspection of its Baddi manufacturing plant.
In a letter (PDF) to the Bombay Stock Exchange, the company said that during the inspection that was conducted Nov. 6-11, the regulatory agency “issued seven observations through the form 483.”
The company did not cite the exact nature of the observations.
"We are in the midst of providing a comprehensive response to the observations and would be replying to the FDA shortly on the observations," the company said in the letter to the exchange.
The Baddi unit, which produces oral solids and liquid doses, makes up about 10% of the company’s sales to the U.S. market.
Following the announcement, Glenmark’s shares slipped about 3% in trading.